LARK INDUSTRIES

FDA Device Registration & Listing · El Paso, TX, US · Registration 3017060084

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017060084
FEI Number
3017060084
Entity Name
LARK INDUSTRIES
City/State/Country
El Paso, TX, US
Establishment Address
7145 Industrial Ave, Suite A-100, El Paso, TX 79915, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Lark Industries (Owner Number: 10074832)
Owner / Operator Contact Address
7145 Industrial Ave, Suite A-100, El Paso, TX 79915, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P950005

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown Class 3 N/A 2020-06-04
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-06-22
MTD Catheter, Intracardiac Mapping, High-Density Array Cardiovascular Class 2 870.1220 2020-06-22
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2020-06-22
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2020-06-22
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2020-06-22
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2020-06-22
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2020-06-22
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2020-06-22
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2020-06-22
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2020-06-22
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2020-06-22
LPB Cardiac Ablation Percutaneous Catheter Unknown Class 3 N/A 2020-06-22
OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown Class 3 N/A 2020-06-22
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2020-06-22
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2020-06-22
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2020-06-22
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2020-06-22
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2020-06-22
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2020-06-22
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-06-22
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2024-06-13
MTD Catheter, Intracardiac Mapping, High-Density Array Cardiovascular Class 2 870.1220 2020-06-22
MTD Catheter, Intracardiac Mapping, High-Density Array Cardiovascular Class 2 870.1220 2020-06-22
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2020-06-22
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2020-06-22
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2020-06-22
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2020-06-22
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2020-06-22
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2020-06-22
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2020-06-22
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2020-06-22
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2020-06-22
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2020-06-22
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2020-06-22
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2020-06-22
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2020-06-22
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-06-22
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2020-06-22
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2020-06-22
MTD Catheter, Intracardiac Mapping, High-Density Array Cardiovascular Class 2 870.1220 2024-11-11
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2020-06-22
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2020-06-22
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2020-06-22
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2020-06-22
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2024-08-02
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2020-06-22
LPB Cardiac Ablation Percutaneous Catheter Unknown Class 3 N/A 2020-06-22
OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown Class 3 N/A 2020-06-22
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2020-06-22

Official Correspondent

Jesse Ornelas

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Lark Industries
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K101883 St Jude Medical 6F ENGAGE/ENGAGE TR INTRODUCER 2010-09-07
K034025 Nmt Medical, Inc. NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC 2004-03-26
K122854 Arrow International (Subsidiary of Teleflex Inc.) ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER 2013-01-04
K233691 Acutus Medical, Inc. FlexCath Cross Transseptal Solution 2023-12-17
K915078 North American Instrument Corp. MORSE HEMOSTATIC CATHETER INTRODUCER SET 1992-06-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0783-2020 Abbott Medical 2
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020 Abbott Medical 2
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0003-2016 Biosense Webster, Inc. 2
SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.
Z-0002-2016 Biosense Webster, Inc. 2
Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05 Siemens Medical Solutions USA, Inc 2
AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017060084. Last updated year: 2026. Please use registration number 3017060084 when referencing this establishment in official correspondence.
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