FDA Registration
Active
🇺🇸 United States
NarrowFlex® Intra-Aortic Balloon (IAB) System
Reg #: 3010532612
·
FEI: 3010532612
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Arrow International, LLC (subsidiary of Teleflex, Incorporated)
- Registration Number
- 3010532612
- FEI Number
- 3010532612
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 16 Elizabeth Dr
- City
- Chelmsford
- State
- MA
- ZIP
- 01824
- Country
- US
Regulatory Submissions
- 510(k) Number
- K993966
Owner / Operator
- Firm Name
- Arrow International LLC (subsidiary of Teleflex Incorporated
- Operator Number
- 2518433
- Address
- 3015 Carrington Mill Blvd.
- City
- Morrisville
- State
- NC
- Postal Code
- 27560
- Country
- US
- Correspondent
- Divya Raman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Balloon, Intra-Aortic And Control | DSP | Class 2 | Cardiovascular | No | 2007-12-14 |
Proprietary Names
NarrowFlex® Intra-Aortic Balloon (IAB) System
NarrowFlex® Intra-Aortic Balloon (IAB) Catheter
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device