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
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(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