Data / Medical devices / United States / Edwards Lifesciences Technology Sarl
Edwards Lifesciences Technology Sarl: FDA-registered device maker in Anasco, PR, United States, 66 510(k) clearances
Edwards Lifesciences Technology Sarl is registered with the FDA (registration 2648045) in Anasco, PR, United States. It lists 32 device types. The FDA files 66 510(k) clearances under its listings, the newest dated June 5, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2648045
- Address
- STATE ROAD 402, KM 1.4, Industrial Park, Anasco, PR, United States, 00610
- Owner or operator
- Becton, Dickinson and Company (10093301)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 28, 2025
- Registered through
- 2026
- Brand names listed
- AVA HF, Acumen AFM Cable, Acumen IQ Fluid Meter, Acumen IQ sensor, Acumen IQ sensor with 60 (152cm) pressure tubing and Acumen IQ fluid meter, Acumen IQ sensor with 60 (152cm) pressure tubing and Acumen IQ fluid meter, 5-pack, Acumen IQ sensor with 60 (152cm) pressure tubing, Acumen IQ fluid meter and VAMP Adult, Acumen IQ sensor with 60 (152cm) pressure tubing, Acumen IQ fluid meter and VAMP Adult with TruWave DPT, 5-pack 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.
| 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 |
| April 10, 2026 | K252378 | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube | JKA | Substantially Equivalent | Becton, Dickinson and Company | 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 |
| August 28, 2024 | K240078 | Fogarty Thru-Lumen Embolectomy Catheter | DXE | 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 27, 2023 | K230493 | BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube | GIM | Substantially Equivalent | Becton, Dickinson and Company | 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 |
| 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 |
| March 10, 2023 | K222478 | BD Vacutainer® Luer-Lok Access Device, BD Vacutainer® Blood Transfer Device | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 16, 2022 | K223243 | BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel Lancets | FMK | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 9, 2022 | K222117 | Swang-Ganz IQ pulmonary artery catheter | DYG | 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 |
| 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 |
| June 16, 2016 | K160645 | PreSep Oligon Oximetry Catheter | DQE | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| May 3, 2016 | K160084 | Swan Ganz Catheters | DYG | 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 |
| September 3, 2014 | K141495 | TRUWAVE DISPOSABLE PRESSURE TRANSDUCER | DXO | 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 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 |
| November 2, 2000 | K002456 | MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | 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 28, 1999 | K991702 | MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578 | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | 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 |
| August 2, 1994 | K940905 | MICROTAINER BRAND TUBE WITH EDTA(K2) | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| July 12, 1979 | K791183 | SWAN-GANZ FLOW-DIRECTED CATHETER | LDF | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 27, 2006 | 36934 | Not yet classified | Terminated | Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75 | Misbranding-One lot of Swan-Ganz Thermodilution VIP Catheters, Model 831HF75, lot 246HC197 was labeled with different model information (831F75) on the edge label. The edge label states the model is 831F75 which incorrectly indicates that product does NOT contain an antimicrobial heparin coating. (The tray lid label correctly states the model is 831HF75, con | accessdata.fda.gov |
| November 2, 2006 | 36817 | Not yet classified | Terminated | Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S | Lack of Assurance of Sterility-Device packaging was manufactured with an incorrect lid that could compromise the sterility of the product. | accessdata.fda.gov |
| October 8, 2003 | 27515 | Not yet classified | Terminated | Edwards Lifesciences Vantex Central Venous Catheter Kit with Oligon, Ref/model #: 3K20C1827, Rx only, Edwards Lifesciences LLC, Irvine, CA 96214-5686 USA | Lot is being recalled because some of the kits contain an incorrect guidewire. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Embolectomy
- All makers of Catheter, Peripheral, Atherectomy
- All makers of Introducer, Catheter
- All makers of Catheter, Oximeter, Fiber-Optic
- All makers of Clamp, Vascular
- All makers of Plethysmograph, Impedance
Updated June 5, 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.