FDA Registration
Active
🇨🇿 Czechia
Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue Plus(R) Catheter
Reg #: 1000563940
·
FEI: 1000563940
·
Expires 2025
Products
1
Proprietary Names
16
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Arrow International CR, a.s.
- Registration Number
- 1000563940
- FEI Number
- 1000563940
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- PRAZSKA 209
- City
- Hradec Kralove
- Country
- CZ
Regulatory Submissions
- 510(k) Number
- K993691
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 | 2007-02-05 |
Proprietary Names
Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue Plus(R) Catheter
ARROWg+ard Blue Plus Multi-Lumen CVC Super Kit
ARROWg+ard Blue Plus Quad-Lumen CVC Set
ARROWg+ard Blue Plus Multi-Lumen CVC Set
ARROWg+ard Blue Plus Two-Lumen CVC
ARROWg+ard Blue Plus Multi-Lumen CVC Extreme Kit
ARROWg+ard Blue Plus Quad-Lumen CVC
AGB+ Two-Lumen CVC Kit
Ag+ Blue Plus ML CVCs
ARROWg+ard Blue Plus Two-Lumen CVC Super Kit
ARROWg+ard Blue Plus Two-Lumen CVC Kit
ARROWg+ard Blue Plus Quad-Lumen CVC Super Kit
ARROWg+ard Blue Plus Multi-Lumen CVC Kit
ARROWg+ard Blue Plus Two-Lumen CVC Set
AGB+ Quad Lumen CVC Kit
AGB+ Multi-Lumen CVC Kit
Establishment Types
Manufacture Medical Device