FDA Registration
Active
🇺🇸 United States
BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS
Reg #: 3017060084
·
FEI: 3017060084
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- LARK INDUSTRIES
- Registration Number
- 3017060084
- FEI Number
- 3017060084
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7145 Industrial Ave, Suite A-100
- City
- El Paso
- State
- TX
- ZIP
- 79915
- Country
- US
Regulatory Submissions
- PMA Number
- P030031
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 Fibrillation | OAE | Class 3 | Unknown | No | 2020-06-22 |
| Cardiac Ablation Percutaneous Catheter | LPB | Class 3 | Unknown | No | 2020-06-22 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2020-06-22 |
Proprietary Names
BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS
Establishment Types
Repack or Relabel Medical Device