FDA Registration
Active
🇲🇽 Mexico
ARROWg+ard Hemodialysis Catheters
Reg #: 9680794
·
FEI: 3003737899
·
Expires 2025
Products
1
Proprietary Names
4
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
- K993933
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, Hemodialysis, Non-Implanted | MPB | Class 2 | Gastroenterology, Urology | No | 2007-12-14 |
Proprietary Names
ARROWg+ard Hemodialysis Catheters
Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter
Two-Lumen Hemodialysis Catheter with Blue FlexTip, ARROWg+ard Blue Catheter
You-Bend Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Repack or Relabel Medical Device