Medical Device Manufacturer · US , Mchenry , IL

Arrow Intl., Inc. - FDA 510(k) Cleared Devices

110 submissions · 105 cleared · Since 1976
110
Total
105
Cleared
0
Denied
110 devices
26-50 of 110
Cleared Jul 12, 2000
19 GA PLASTIC REINFORCED EPIDURAL CATHETER
K001587 · CAZ
Anesthesiology · 50d
Cleared May 19, 2000
ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
K000729 · DSP
Cardiovascular · 74d
Cleared Mar 08, 2000
ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
K993691 · FOZ
General Hospital · 128d
Cleared Feb 18, 2000
8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER
K993966 · DSP
Cardiovascular · 87d
Cleared May 26, 1999
14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT
K991431 · MPB
Gastroenterology & Urology · 30d
Cleared May 18, 1999
PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
K984022 · MPB
Gastroenterology & Urology · 187d
Cleared May 04, 1999
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509...
K990829 · MCW
Cardiovascular · 53d
Cleared Aug 31, 1998
ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025
K982141 · DXE
Cardiovascular · 75d
Cleared Aug 12, 1998
LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT...
K981782 · DYB
Cardiovascular · 84d
Cleared Jun 04, 1998
IAB-04840-U
K970689 · DSP
Cardiovascular · 464d
Cleared Feb 13, 1998
ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET
K970229 · DYB
Cardiovascular · 388d
Cleared Jan 23, 1998
ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)
K965209 · DSP
Cardiovascular · 392d
Cleared Oct 17, 1997
ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS
K970864 · FOZ
General Hospital · 221d
Cleared Sep 16, 1997
8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT...
K963865 · DSP
Cardiovascular · 357d
Cleared Aug 21, 1997
ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER
K962577 · FOZ
General Hospital · 416d
Cleared Jul 25, 1997
ARROW-TREROTOLA PTD CATHETER
K970080 · MCW
Cardiovascular · 197d
Cleared Jun 17, 1997
8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER,
K963920 · DSP
Cardiovascular · 260d
Cleared Mar 04, 1997
PERIPHERALLY INSERTED MEDLINE CATHETER
K963257 · LJS
General Hospital · 197d
Cleared Feb 04, 1997
9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM
K963104 · DSP
Cardiovascular · 179d
Cleared Oct 24, 1996
A2 PORT, DUAL LUMEN SYSTEM WITH DETACHED CATHETER, CATALOG # AP-01518 (MODIFIED)
K963684 · LJT
General Hospital · 73d
Cleared Oct 17, 1996
ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER
K960479 · LDF
Cardiovascular · 258d
Cleared Jul 19, 1996
LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG #1037
K961615 · LJT
General Hospital · 84d
Cleared Jul 19, 1996
LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017
K961652 · LJT
General Hospital · 80d
Cleared Jul 18, 1996
A PORT DETACHED CATHETER SYSTEM CATALOG #1002
K961583 · LJT
General Hospital · 85d
Cleared Jul 02, 1996
NON-CORING NEEDLE
K961088 · FMI
General Hospital · 105d

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