DSP · Class II · 21 CFR 870.3535

FDA Product Code DSP: System, Balloon, Intra-aortic And Control

Leading manufacturers include Datascope Corp., Kontron Instruments, Inc. and Arrow Intl., Inc..

162
Total
161
Cleared
171d
Avg days
1976
Since
162 devices
25–48 of 162
Cleared Oct 20, 2000
MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC
K002949
Datascope Corp.
Cardiovascular · 29d
Cleared May 19, 2000
ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
K000729
Arrow Intl., Inc.
Cardiovascular · 74d
Cleared Mar 13, 2000
DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329
K994157
Datascope Corp.
Cardiovascular · 95d
Cleared Feb 18, 2000
8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER
K993966
Arrow Intl., Inc.
Cardiovascular · 87d
Cleared Oct 16, 1998
Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters
K981660
C.R. Bard, Inc.
Cardiovascular · 158d
Cleared Jun 04, 1998
IAB-04840-U
K970689
Arrow Intl., Inc.
Cardiovascular · 464d
Cleared Jun 03, 1998
BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS
K980850
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared May 29, 1998
DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES
K980780
Datascope Corp.
Cardiovascular · 88d
Cleared May 01, 1998
DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES
K980385
Datascope Corp.
Cardiovascular · 88d
Cleared Feb 19, 1998
BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS
K973962
C.R. Bard, Inc.
Cardiovascular · 126d
Cleared Feb 10, 1998
40 CC GRANDE
K974247
Boston Scientific Corp
Cardiovascular · 90d
Cleared Jan 23, 1998
ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)
K965209
Arrow Intl., Inc.
Cardiovascular · 392d
Cleared Sep 16, 1997
8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S
K963865
Arrow Intl., Inc.
Cardiovascular · 357d
Cleared Sep 02, 1997
30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL
K972113
Boston Scientific Corp
Cardiovascular · 89d
Cleared Aug 05, 1997
40 CC SUMO
K971673
Boston Scientific Corp
Cardiovascular · 90d
Cleared Jul 01, 1997
SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)
K965236
Datascope Corp.
Cardiovascular · 182d
Cleared Jun 17, 1997
8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER,
K963920
Arrow Intl., Inc.
Cardiovascular · 260d
Cleared Mar 17, 1997
DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0
K964987
Datascope Corp.
Cardiovascular · 94d
Cleared Feb 04, 1997
9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM
K963104
Arrow Intl., Inc.
Cardiovascular · 179d
Cleared Nov 15, 1996
INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED
K961509
Datascope Corp.
Cardiovascular · 210d
Cleared Nov 04, 1996
MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C
K963187
Boston Scientific Corp
Cardiovascular · 82d
Cleared Sep 04, 1996
BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT
K962177
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Jul 02, 1996
ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER
K961358
Arrow Intl., Inc.
Cardiovascular · 85d
Cleared May 15, 1996
8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODUCT NUMBER IAB-04840(USED WITH A 9FR.SHEATH)
K960713
Arrow Intl., Inc.
Cardiovascular · 84d