Medical Device Manufacturer · US , Reading , PA

Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

8 submissions · 7 cleared · Since 2015
8
Total
7
Cleared
0
Denied

Arrow International, Inc. (Subsidiary of Teleflex, Inc.) — FDA 510(k) Submissions

Arrow International, Inc. (Subsidiary of Teleflex, Inc.) has submitted 8 FDA 510(k) premarket notifications since 2015, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days, Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days, Wire, Guide, Catheter, Midline Catheter, Needle, Hypodermic, Single Lumen . Use the specialty filter in the sidebar to narrow results.

8 devices
1–8 of 8
EZ-IO Intraosseous Vascular Access System
K180395 · FMI Needle, Hypodermic,... · General Hospital
Nov 2018 269d
Arrow Endurance Extended Dwell Peripheral Catheter System
K163513 · FOZ Catheter, Intravascular,... · General Hospital
Feb 2017 71d
ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology
K161313 · PND Midline Catheter · General Hospital
Aug 2016 106d
Arrow Quickflash Arterial Catheterization Device
K160018 · DQX Wire, Guide, Catheter · Cardiovascular
Jun 2016 160d
CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS
K153487 · LJS Catheter, Intravascular,... · General Hospital
Feb 2016 62d
CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC
K153423 · LJS Catheter, Intravascular,... · General Hospital
Jan 2016 64d
Arrow Endurance Extended Dwell Peripheral Catheter System
K152272 · FOZ Catheter, Intravascular,... · General Hospital
Nov 2015 103d
Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions
K143102 · NIE Catheter, Hemodialysis,... · Gastroenterology & Urology
Jul 2015 268d
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