Data / Medical devices / United States / Becton, Dickinson And Company
Becton, Dickinson And Company: FDA-registered device maker in Irvine, CA, United States, 101 510(k) clearances
Becton, Dickinson And Company is registered with the FDA (registration 3032916632) in Irvine, CA, United States. It lists 36 device types. The FDA files 101 510(k) clearances under its listings, the newest dated June 5, 2026. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3032916632
- Address
- 17200 Laguna Canyon Rd, Irvine, CA, United States, 92618
- Owner or operator
- Becton, Dickinson and Company (10093301)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- April 26, 2025
- Registered through
- 2026
- Brand names listed
- AFM Feature with AFM Prompt Reclassifier algorithm (AFM PR algorithm), Accumen IQ finger cuff, Acumen AFM Cable, Acumen AFM cable - HemoSphere Alta monitor, Acumen Assisted Fluid Management, Acumen Assisted Fluid Management (AFM) Software Feature, Acumen Hypotension Prediction Index, Acumen Hypotension Prediction Index Feature and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 101.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 5, 2026 | K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts | DXC | Substantially Equivalent | Edwards Lifesciences | accessdata.fda.gov |
| February 24, 2026 | K253186 | HemoSphere Nano Monitor (HSNANO1) | DQK | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| December 18, 2025 | K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | DQK | Substantially Equivalent | Edwards Lifesciences | accessdata.fda.gov |
| October 21, 2025 | K253034 | HemoSphere Stream Module | DQK | Substantially Equivalent | Edwards Lifesciences | accessdata.fda.gov |
| July 23, 2025 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) | DQK | Substantially Equivalent | Edwards Lifesciences | accessdata.fda.gov |
| March 21, 2025 | K242909 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | DRS | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| December 9, 2024 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) | DYG | Substantially Equivalent | Edwards Lifesciences | accessdata.fda.gov |
| August 28, 2024 | K240078 | Fogarty Thru-Lumen Embolectomy Catheter | DXE | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| August 2, 2024 | K233984 | Acumen Assisted Fluid Management (AFM) Software Feature | QMS | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| July 2, 2024 | K241330 | Fogarty Fortis Arterial Embolectomy Catheter | DXE | Substantially Equivalent | Edwards Lifesciences | accessdata.fda.gov |
| June 27, 2024 | K233983 | Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) | DYG | Substantially Equivalent | Edwards Lifesciences | accessdata.fda.gov |
| June 6, 2024 | K233824 | Swan-Ganz catheter | DYG | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| May 22, 2024 | K233820 | Fogarty Arterial Embolectomy Catheter with Gate Valve | DXE | Substantially Equivalent | Edwards Lifesciences | accessdata.fda.gov |
| May 22, 2024 | K233819 | Fogarty Venous Thrombectomy Catheters | DXE | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| May 20, 2024 | K233619 | Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters | DXE | Substantially Equivalent | Edwards Lifesciences | accessdata.fda.gov |
| November 17, 2023 | K230612 | Edwards Algorithm for Measurement of Blood Hemoglobin | MUD | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| October 31, 2023 | K232294 | HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta Advanced Monitor (Smart Recovery); HemoSphere Alta Advanced Monitor (Cardiac); HemoSphere Alta Advanced Monitor (All-on-One) | DQK | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| October 24, 2023 | K230919 | Acumen IQ finger cuff | DXN | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| September 21, 2023 | K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform | DYG | Substantially Equivalent | Edwards Lifesciencess, LLC | accessdata.fda.gov |
| July 12, 2023 | K231035 | FusedCO Algorithm | DQK | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| June 9, 2023 | K223865 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor | DQK | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| December 22, 2022 | K222216 | TruWave Disposable Pressure Transducer | DXO | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| December 9, 2022 | K222117 | Swang-Ganz IQ pulmonary artery catheter | DYG | Substantially Equivalent | Edwards Lifesiences, LLC | accessdata.fda.gov |
| June 22, 2022 | K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote | DQK | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| May 28, 2021 | K203687 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index | DQK | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| January 22, 2021 | K203131 | EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform | DXN | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| October 1, 2020 | K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | DQK | Substantially Equivalent | Edwards Lifesiences, LLC | accessdata.fda.gov |
| June 12, 2020 | K193379 | Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe | DXE | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| February 16, 2020 | K193466 | Swan-Ganz Catheters | DYG | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| August 29, 2019 | K190205 | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | DQK | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| June 21, 2019 | K190130 | The ClearSight finger cuffs | DXN | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| June 13, 2019 | K191089 | Edwards Pressure Cable | DQK | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| May 1, 2019 | K183413 | TruWave Disposable Pressure Transducer | DXO | Substantially Equivalent | Edwards Lifeciences, LLC | accessdata.fda.gov |
| November 30, 2018 | K182245 | EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System | DXN | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| November 16, 2018 | K180881 | HemoSphere Advanced Monitor, HemoSphere Pressure Cable | DQK | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| November 8, 2018 | K181684 | VAMP Plus Venous/Arterial Blood Management Protection System | KRA | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| October 24, 2018 | K180275 | VAMP Optima closed blood sampling system | KRA | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| May 10, 2018 | K180003 | FORE-SIGHT ELITE Module Tissue Oximeter | MUD | Substantially Equivalent | Cas Medical Systems, Inc. | accessdata.fda.gov |
| April 5, 2018 | K173586 | VAMP Venous/Arterial Blood Management Protection System | KRA | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| February 20, 2018 | K172423 | PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) | DQE | Substantially Equivalent | Edwards Lifescience, LLC | accessdata.fda.gov |
| November 17, 2017 | K172660 | Duravess bovine pericardial vascular patch | PSQ | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| October 23, 2017 | K171996 | TruWave Disposable Pressure Transducer | DXO | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| April 14, 2017 | K163381 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable | DQK | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| November 28, 2016 | K161962 | VAMP Venous/Arterial Blood Management Protection System | KRA | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| June 16, 2016 | K160645 | PreSep Oligon Oximetry Catheter | DQE | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| June 1, 2016 | K160552 | EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform | DXN | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| May 3, 2016 | K160084 | Swan Ganz Catheters | DYG | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| January 19, 2016 | K152980 | Flo Trac sensor, Volume View sensor | DRS | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| November 23, 2015 | K152762 | Fogarty Occlusion Catheter | MJN | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| October 15, 2015 | K152633 | Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe | LDF | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| April 10, 2015 | K143675 | FORE-SIGHT Elite Absolute Tissue Oximeter | MUD | Substantially Equivalent | Cas Medical Systems, Inc. | accessdata.fda.gov |
| January 18, 2015 | K142749 | TruWave Disposable Pressure Transducer | DXO | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| September 3, 2014 | K141495 | TRUWAVE DISPOSABLE PRESSURE TRANSDUCER | DXO | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| June 13, 2014 | K140312 | EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM | DXN | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| May 22, 2014 | K131892 | EV1000 CLINICAL PLATFORM | DXG | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| May 22, 2014 | K131588 | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR | DXG | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| February 18, 2011 | K110167 | PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) | DQE | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| December 7, 2010 | K100739 | VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 | KRB | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| January 21, 2010 | K093911 | FOGARTY OCCLUSION CATHETER | MJN | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| April 28, 2006 | K060093 | PRESEP OLIGON OXIMETRY CATHETERS | DQE | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| February 28, 2006 | K053609 | PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR | DQE | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| December 9, 2004 | K043103 | VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2 | DXG | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| December 30, 2003 | K033250 | EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR | FOZ | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| October 2, 2003 | K032587 | EDWARDS PERIPHERAL DILATATION CATHETER | DQY | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| June 20, 2003 | K030944 | EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL | DYB | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| April 24, 2003 | K031087 | EDWARDS INTRODUCER SHEATH | DYB | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| March 8, 2002 | K014054 | EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL | DQO | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| July 7, 2000 | K001063 | SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 | DYG | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| July 30, 1999 | K983802 | LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB | MJN | Substantially Equivalent | Lucas Medical, Inc. | accessdata.fda.gov |
| November 27, 1995 | K951566 | SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH] | DYG | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| February 7, 1995 | K942457 | GRAFT THROMBECTOMY INSTRUMENTS | MCW | Substantially Equivalent | Intramed Laboratories, Inc. | accessdata.fda.gov |
| May 24, 1994 | K940795 | SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER | DYG | Substantially Equivalent | Baxter Edwards | accessdata.fda.gov |
| January 24, 1994 | K934742 | SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT | DYG | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| October 29, 1993 | K924452 | SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER | DYG | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| October 18, 1993 | K925638 | PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600 | DXO | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| April 8, 1993 | K924661 | SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER | KRA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| February 22, 1993 | K926450 | EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH | DQE | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| September 21, 1992 | K915726 | PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH | DQO | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| April 24, 1991 | K910204 | SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM) | DQO | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| February 13, 1991 | K905707 | BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS | FGE | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| February 7, 1991 | K905458 | SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER | DQE | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| September 11, 1990 | K901736 | OXIMETRY PROBE CATHETERS | DQE | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| July 6, 1990 | K901625 | FOGARTY ARTERIAL EMBOLECTOMY II CATHETER | DXE | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| February 8, 1990 | K896466 | SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME | DYG | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| January 19, 1990 | K896819 | VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION | KRA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| July 20, 1989 | K892410 | FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER | DXE | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| January 6, 1987 | K864330 | SHEAR FORCE GAUGE | DXE | Substantially Equivalent | American Edwards Laboratories | accessdata.fda.gov |
| September 29, 1983 | K832554 | FOGARTY 6MM SOFTJAW CLIP | DXC | Substantially Equivalent | American Edwards Laboratories | accessdata.fda.gov |
| October 15, 1982 | K822723 | SWAN-GANZ BIPOLAR PACING CATHETER | DYG | Substantially Equivalent | American Edwards Laboratories | accessdata.fda.gov |
| August 24, 1982 | K822350 | SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH | DYG | Substantially Equivalent | American Edwards Laboratories | accessdata.fda.gov |
| July 2, 1982 | K821416 | DISPOSABLE BLOOD PRESSURE TRANSDUCER | DRS | Substantially Equivalent | Bentley Laboratories, Inc. | accessdata.fda.gov |
| March 15, 1982 | K813521 | TRANSLUMINAL BIPOLAR PACING PROBE | LDF | Substantially Equivalent | American Edwards Laboratories | accessdata.fda.gov |
| February 12, 1982 | K820222 | SWAN-GANZ VIP-CATHETER | DYG | Substantially Equivalent | American Edwards Laboratories | accessdata.fda.gov |
| September 25, 1981 | K812563 | SWAN-GANZ & EDSLAB HEPARIN COATED CATH. | DYG | Substantially Equivalent | American Edwards Laboratories | accessdata.fda.gov |
| June 12, 1981 | K811411 | SWAN-GANZ HEPARIN COATED, ETC. CATHETER | KRB | Substantially Equivalent | American Edwards Laboratories | accessdata.fda.gov |
| June 9, 1981 | K811399 | EDSLAB CLOSED INJECTATE DELIVERY SYSTEM | KRB | Substantially Equivalent | American Edwards Laboratories | accessdata.fda.gov |
| March 27, 1981 | K810352 | SWAN-GANZ FLOW-DIRECTED THERMODILUTION | DYG | Substantially Equivalent | American Edwards Laboratories | accessdata.fda.gov |
| February 4, 1981 | K810162 | FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06 | DXC | Substantially Equivalent | American Edwards Laboratories | accessdata.fda.gov |
| February 4, 1981 | K810124 | SWAN-GANZ VIP THERMODILUTION CATHETER | DYG | Substantially Equivalent | American Edwards Laboratories | accessdata.fda.gov |
| January 16, 1981 | K803058 | SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH. | LDF | Substantially Equivalent | American Edwards Laboratories | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 11, 2026 | 99370 | Class II | Ongoing | ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of bloo | Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables. | accessdata.fda.gov |
| April 8, 2026 | 98603 | Class II | Ongoing | Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8 | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Catheter, Embolectomy
- All makers of Computer, Diagnostic, Programmable
- All makers of Computer, Diagnostic, Pre-Programmed, Single-Function
- All makers of Transducer, Pressure, Catheter Tip
- All makers of Catheter, Flow Directed
Updated September 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.