FDA Registration
Active
🇲🇽 Mexico
NextStep Retrograde Replacement Hub Set
Reg #: 9680794
·
FEI: 3003737899
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Arrow Internacional de Chihuahua S.A. de C.V.
- Registration Number
- 9680794
- FEI Number
- 3003737899
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Ave. Washington 3701, Interior Circuito Industrial, Alta Tecnologia Edificios 2, 4, 36 and 40, Colonia Panamericana
- City
- CHIHUAHUA
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K020430
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 |
|---|---|---|---|---|---|
| Kit, Repair, Catheter, Hemodialysis | NFK | Class 2 | Gastroenterology, Urology | No | 2008-02-15 |
Proprietary Names
NextStep Retrograde Replacement Hub Set
Cannon II Plus Replacement Hub Set
Establishment Types
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device