Arrow Intl., Inc. - FDA 510(k) Cleared Devices
Recent clearances: ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504, ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520, ARROW INTERNATIONAL, INC., SURGICAL DRAPES
110
Total
105
Cleared
0
Denied
FDA 510(k) Regulatory Record - Arrow Intl., Inc. Cardiovascular ✕
55 devices
Cleared
Dec 18, 2009
ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520
Cardiovascular
79d
Cleared
Apr 06, 2006
AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES
Cardiovascular
58d
Cleared
May 06, 2004
INTRA-AORTIC BALLOON (IAB)
Cardiovascular
38d
Cleared
Mar 01, 2004
ARROW ECHOGENIC INTRODUCER NEEDLE
Cardiovascular
41d
Cleared
Nov 25, 2003
MONITOR, MODEL HSM-00200
Cardiovascular
228d
Cleared
Aug 08, 2002
SHEATH ADAPTER, MODEL SA-09847
Cardiovascular
76d
Cleared
Jun 06, 2002
ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A...
Cardiovascular
30d
Cleared
May 02, 2002
RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL...
Cardiovascular
24d
Cleared
Oct 31, 2001
MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE...
Cardiovascular
147d
Cleared
Oct 24, 2001
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD
Cardiovascular
201d
Cleared
May 03, 2001
ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
Cardiovascular
282d
Cleared
Mar 21, 2001
TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT
Cardiovascular
218d
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