FDA Registration
Active
🇺🇸 United States
Conquest 40 PTA Dilatation Catheter
Reg #: 2020394
·
FEI: 2020394
·
Expires 2025
Products
4
Proprietary Names
4
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- BARD PERIPHERAL VASCULAR, INC.
- Registration Number
- 2020394
- FEI Number
- 2020394
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1625 W 3rd St
- City
- TEMPE
- State
- AZ
- ZIP
- 85281
- Country
- US
Regulatory Submissions
- 510(k) Number
- K212588
Owner / Operator
- Firm Name
- C. R. Bard, Inc.
- Operator Number
- 2212754
- Address
- 1 Becton Drive
- City
- Franklin Lakes
- State
- NJ
- Postal Code
- 07417
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2022-05-20 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2022-05-20 |
| Balloon Aortic Valvuloplasty | OZT | Class 2 | Cardiovascular | No | 2022-05-20 |
| Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter | OMZ | Class 2 | Cardiovascular | No | 2022-05-20 |
Proprietary Names
Conquest 40 PTA Dilatation Catheter
Atlas Gold PTA Dilatation Catheter
Vida PTV Dilatation Catheter
Vida BAV Balloon Valvuloplasty Catheter
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility