FDA Registration Active 🇲🇽 Mexico

Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue Plus(R) Catheter

Reg #: 9680794 · FEI: 3003737899 · Expires 2025
Products
1
Proprietary Names
16
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
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
Phone
612 4231738

Products

Device Name Product Code
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ

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

Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device Manufacture Medical Device