Data / Medical devices / United States / Lark Industries
Lark Industries: FDA-registered device maker in El Paso, TX, United States, 61 510(k) clearances and 6 PMA approvals
Lark Industries is registered with the FDA (registration 3017060084) in El Paso, TX, United States. It lists 13 device types. The FDA files 61 510(k) clearances and 6 PMA approvals under its listings, the newest dated March 18, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017060084
- Address
- 7145 Industrial Ave Suite A-100, El Paso, TX, United States, 79915
- Owner or operator
- Lark Industries (10074832)
- Roles
- Repackager or relabeler
- First device listed
- June 4, 2020
- Registered through
- 2026
- Brand names listed
- Acclarent ENT Navigation System, BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220, BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS, BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES, Biosense Webster Cables, CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN, CARTO 3 EP NAVIGATION SYSTEM, V1 AND ACCESSORIES, CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2 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 |
|---|---|---|---|---|---|---|
| March 18, 2022 | K211438 | OPTRELL Mapping Catheter with TRUEref Technology | MTD | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| January 26, 2022 | K211219 | LASSOSTAR NAV Circular Mapping Catheter | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| March 5, 2021 | K201775 | NuVision ICE Catheter | OBJ | Substantially Equivalent | Nuvera Medical, Inc. | accessdata.fda.gov |
| July 31, 2020 | K193237 | Carto Octaray Mapping Catheter with Trueref Technology | MTD | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| January 30, 2020 | K192397 | TruDi Navigation System | PGW | Substantially Equivalent | Biosense Webster | accessdata.fda.gov |
| August 24, 2018 | K173978 | CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 14, 2018 | K173977 | CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 1, 2018 | K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| March 10, 2018 | K173628 | Acclarent ENT Navigation System | PGW | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| July 25, 2017 | K170997 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath | DYB | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| July 25, 2017 | K170600 | CARTO 3 EP Navigation System, Version 6.0 and Accessories | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| July 1, 2014 | K133916 | CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| March 12, 2014 | K140318 | SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER | OBJ | Substantially Equivalent | Biosense Webster | accessdata.fda.gov |
| January 24, 2014 | K132782 | CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2 | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| August 14, 2013 | K130602 | LASSO NAV DUO LOOP CATHETER | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| March 5, 2013 | K123837 | PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER | MTD | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| May 24, 2012 | K120425 | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER | MTD | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| May 7, 2012 | K120550 | CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD) | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| December 5, 2011 | K113213 | LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| November 18, 2011 | K112050 | SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER | OBJ | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| October 5, 2011 | K112007 | CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2 | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| May 2, 2011 | K101991 | WEBSTER DUO-DECAPOLAR CATHETER | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 22, 2010 | K101345 | WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 22, 2010 | K101138 | SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 | OBJ | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 18, 2010 | K093566 | CARTO XP EP NAVIGATION SYSTEM, VERSION 10 | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 18, 2010 | K093376 | LASSO NAV CATHETER | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| December 4, 2009 | K093455 | CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| December 4, 2009 | K091352 | SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05 | OBJ | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| October 13, 2009 | K090017 | CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| October 1, 2009 | K091789 | CARTO RMT EP NAVIGATION SYSTEM V8 | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| September 4, 2009 | K090898 | CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| August 7, 2009 | K092064 | SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12 | OBJ | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| March 24, 2009 | K090120 | REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106 | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| January 6, 2009 | K081258 | VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02 | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| April 23, 2008 | K080425 | CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02 | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| November 19, 2007 | K072202 | CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01) | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| May 15, 2007 | K070242 | SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05 | OBJ | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| August 14, 2006 | K061468 | REFSTAR EXTERNAL REFERENCE PATCH | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| August 14, 2006 | K061463 | ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| March 9, 2006 | K053194 | NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| September 29, 2005 | K052083 | NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| September 29, 2005 | K042998 | REFSTAR RMT EXTERNAL REFERENCE PATCH | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 24, 2005 | K050877 | CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| March 30, 2005 | K050217 | FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING) | MTD | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| July 22, 2003 | K031161 | VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| August 31, 2000 | K002333 | BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220 | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| July 21, 2000 | K001390 | BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES | DSA | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| May 10, 2000 | K001139 | PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M | DYB | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| November 26, 1999 | K992965 | CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 | DRF | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| October 4, 1999 | K991531 | CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 | DRF | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| August 28, 1998 | K982740 | CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S | DYB | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| August 10, 1998 | K982415 | CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 | DRF | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| May 28, 1998 | K980961 | CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. | DRF | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| October 28, 1997 | K970264 | CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM | DYB | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| September 18, 1996 | K953663 | CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | DRF | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| March 25, 1996 | K955817 | CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER | DRF | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| December 21, 1995 | K954390 | CORDIS WESTER STAR CATHETER | DRF | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| November 22, 1995 | K953768 | CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | DRF | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| December 3, 1985 | K853383 | CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN | DYG | Substantially Equivalent | Webster Laboratories, Inc. | accessdata.fda.gov |
| October 18, 1984 | K841802 | ELECTRODE CATHETER, ORTHOGONAL TYPE | LDF | Substantially Equivalent | Webster Laboratories, Inc. | accessdata.fda.gov |
| May 9, 1984 | K834602 | SWITCHING UNIT ELECTRODE CATHETER | DRF | Substantially Equivalent | Webster Laboratories, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 11, 2006 | P040036 | NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER | LPB | 92 | September 15, 2026 | accessdata.fda.gov |
| November 5, 2004 | P030031 | BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS | OAD | 135 | September 15, 2026 | accessdata.fda.gov |
| September 27, 2002 | P010068 | NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER | OAD | 73 | February 26, 2025 | accessdata.fda.gov |
| June 15, 2000 | P990025 | NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER | DRF | 72 | February 25, 2025 | accessdata.fda.gov |
| May 31, 2000 | P990071 | STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR | LPB | 65 | December 23, 2025 | accessdata.fda.gov |
| September 30, 1997 | P950005 | WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER | LPB | 86 | February 26, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Cable, Transducer And Electrode, Patient, (Including Connector)
- All makers of Catheter, Ultrasound, Intravascular
- All makers of Catheter, Electrode Recording, Or Probe, Electrode Recording
- All makers of Catheter, Intracardiac Mapping, High-Density Array
- All makers of Computer, Diagnostic, Programmable
- All makers of Cardiac Ablation Percutaneous Catheter
Updated September 15, 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.