FDA Registration
Active
🇨🇿 Czechia
Arrow "No Leak" Sheath Adapter with Side Port
Reg #: 3006425876
·
FEI: 3006425876
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Arrow International C.R. a.s.
- Registration Number
- 3006425876
- FEI Number
- 3006425876
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- JAMSKA 2359/47
- City
- ZDAR NAD SAZAVOU Vysocina
- Country
- CZ
Regulatory Submissions
- 510(k) Number
- K781846
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
US Agent
- Business Name
- Teleflex, Inc.
- Contact Name
- Divya Raman
- Address
- 3015 Carrington Mill Boulevard
- City
- Morrisville
- State
- NC
- ZIP
- 27560
- Country
- US
- [email protected]
- Phone
- 612 4231738
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2008-02-15 |
Proprietary Names
Arrow "No Leak" Sheath Adapter with Side Port
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device
Manufacture Medical Device