FDA Registration
Active
🇨🇿 Czechia
Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter
Reg #: 3006425876
·
FEI: 3006425876
·
Expires 2025
Products
1
Proprietary Names
2
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
- K900263
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 |
|---|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2007-12-13 |
Proprietary Names
Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter
ARROWg+ard CVCs
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device