FDA Registration
Active
🇺🇸 United States
LARK INDUSTRIES
Reg #: 3017060084
·
FEI: 3017060084
·
Expires 2026
Products
12
Proprietary Names
66
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- LARK INDUSTRIES
- Registration Number
- 3017060084
- FEI Number
- 3017060084
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7145 Industrial Ave, Suite A-100
- City
- El Paso
- State
- TX
- ZIP
- 79915
- Country
- US
Regulatory Submissions
- 510(k) Number
- K001139
- PMA Number
- P010068
Owner / Operator
- Firm Name
- Lark Industries
- Operator Number
- 10074832
- Address
- 7145 Industrial Ave, Suite A-100
- City
- El Paso
- State
- TX
- Postal Code
- 79915
- Country
- US
- Correspondent
- Jesse Ornelas
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2020-06-04 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2020-06-22 |
| Catheter, Intracardiac Mapping, High-Density Array | MTD | Class 2 | Cardiovascular | No | 2020-06-22 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2020-06-22 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2020-06-22 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2020-06-22 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2020-06-22 |
| Cardiac Ablation Percutaneous Catheter | LPB | Class 3 | Unknown | No | 2020-06-22 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2020-06-22 |
| Electrode, Pacemaker, Temporary | LDF | Class 2 | Cardiovascular | No | 2020-06-22 |
| Catheter, Flow Directed | DYG | Class 2 | Cardiovascular | No | 2020-06-22 |
| Ear, Nose, And Throat Stereotaxic Instrument | PGW | Class 2 | Neurology | No | 2020-06-22 |
Proprietary Names
Celsius DS Catheter, EZ Steer DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter, EZ Steer DS NAV Catheter
PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M
FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING)
SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12
CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER
CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02
BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES
CARTO RMT EP NAVIGATION SYSTEM V8
CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER
CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085
CARTO 3 VERSION 15 EP NAVIGATION SYSTEM AND ACCESSORIES
CARTO 3 EP Navigation System, Version 5.2 And Accessories With CARTOFINDER Module
BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS
SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12
CARTO 3 EP NAVIGATION SYSTEM, V1 AND ACCESSORIES
NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER
LASSO NAV DUO LOOP CATHETER
LASSO NAV CATHETER
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
CORDIS WEBSTER NUVISION ICE CATHETER 10FR
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02
SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2
CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER
VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER
REFSTAR RMT EXTERNAL REFERENCE PATCH
CARTO(R) EP NAVIGATION SYSTEM, VERSION 3 (WITH STANDARD LOCATION PAD)
ELECTRODE CATHETER, ORTHOGONAL TYPE
CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2
CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN
NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE
CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01)
CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR
CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM
WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,
SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05
D-1409-02-S
ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S
CARTO 3 EP Navigation System, Version 6 And Accessories
SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER
CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2
LASSOSTAR NAV Circular Mapping Catheter
CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.
Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter, EZ Steer Catheter, EZ St
TruDi Navigation System
CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER
CARTO 3 EP Navigation System, Version 4.35 And Accessories With COHERENT MAP Module
CORDIS WESTER STAR CATHETER
Acclarent ENT Navigation System
LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2
CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210
SWITCHING UNIT ELECTRODE CATHETER
WEBSTER DUO-DECAPOLAR CATHETER
CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078
EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter, And Biosense Webster Cables
CARTO XP EP NAVIGATION SYSTEM, VERSION 10
CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S
BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220
Biosense Webster Cables
REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106
SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER
THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter, Navigation Catheter
CARTO 3 EP Navigation System, Version 6 And Accessories With VISITAG SURPOINT
REFSTAR EXTERNAL REFERENCE PATCH
Establishment Types
Repack or Relabel Medical Device