Medical Device Manufacturer · US , Reading , PA

Arrow International, Inc.

19 submissions · 17 cleared · Since 2003
19
Total
17
Cleared
0
Denied

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

Arrow International, Inc. has submitted 19 FDA 510(k) premarket notifications since 2003, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days, System, Balloon, Intra-aortic And Control, Catheter, Hemodialysis, Implanted, Anesthesia Conduction Kit, Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days . Use the specialty filter in the sidebar to narrow results.

19 devices
1–19 of 19
AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
K201112 · DSP System, Balloon,... · Cardiovascular
May 2020 30d
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
K200634 · DSP System, Balloon,... · Cardiovascular
Apr 2020 30d
UltraFlex IAB
K190101 · DSP System, Balloon,... · Cardiovascular
Jun 2019 157d
Fiberoptix IAB
K190117 · DSP System, Balloon,... · Cardiovascular
Jun 2019 140d
AC3 Series IABP System
K162820 · DSP System, Balloon,... · Cardiovascular
Mar 2017 175d
VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU
K141051 · MSD Catheter, Hemodialysis,... · Gastroenterology & Urology
Jul 2014 74d
NEXTSTEP RETROGRADE
K130192 · MSD Catheter, Hemodialysis,... · Gastroenterology & Urology
May 2013 105d
CG+ ARROW PICC POWERED BY ARROW VPS STYLET
K130876 · LJS Catheter, Intravascular,... · General Hospital
Apr 2013 28d
ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE
K122690 · CAZ Anesthesia Conduction Kit · Anesthesiology
Dec 2012 108d
ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER
K122027 · CAZ Anesthesia Conduction Kit · Anesthesiology
Aug 2012 48d
ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS
K113277 · LJS Catheter, Intravascular,... · General Hospital
Jun 2012 227d
PRESSURE INJFECTABLE PICC
K080604 · LJS Catheter, Intravascular,... · General Hospital
Jun 2008 115d
PRESSURE INJECTABLE PICC
K073451 · LJS Catheter, Intravascular,... · General Hospital
Jan 2008 36d
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER
K071538 · FOZ Catheter, Intravascular,... · General Hospital
Aug 2007 86d
ARROW PRESSURE INJECTABLE PICC
K061289 · LJS Catheter, Intravascular,... · General Hospital
Aug 2006 107d
SILICONE COATED GUIDEWIRE
K041740 · DQX Wire, Guide, Catheter · Cardiovascular
Oct 2004 109d
STEP-TIP CHRONIC HEMODIALYSIS CATHETER
K040666 · MSD Catheter, Hemodialysis,... · Gastroenterology & Urology
May 2004 60d
CANNON II PLUS
K040078 · MSD Catheter, Hemodialysis,... · Gastroenterology & Urology
Feb 2004 30d
STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK
K030937 · CAZ Anesthesia Conduction Kit · Anesthesiology
Apr 2003 29d
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