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
49–72 of 162
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
Cleared Apr 24, 1996
PERCOR STAT-DL 9.5 FR. 34 & 40CC
K960166
Datascope Corp.
Cardiovascular · 99d
Cleared Jan 11, 1996
PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS
K954431
Boston Scientific Corp
Cardiovascular · 108d
Cleared Dec 26, 1995
TRANSPORT CART
K952576
Belmont Instrument Corp.
Cardiovascular · 204d
Cleared Aug 11, 1995
BSC/CA 30 & 40 SENSATION, MODELS 930 & 940
K952221
Boston Scientific Corp
Cardiovascular · 91d
Cleared May 24, 1995
EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP)
K950687
Belmont Instrument Corp.
Cardiovascular · 99d
Cleared May 09, 1995
ARROW KINK RESISTANT FLEXI-CATH INTRA-AORTIC BALLOON
K945230
Arrow Intl., Inc.
Cardiovascular · 195d
Cleared Apr 06, 1995
BSC/CA MODEL 940 IAB
K940298
Boston Scientific Corp
Cardiovascular · 440d
Cleared Mar 23, 1995
9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER
K943919
Boston Scientific Corp
Cardiovascular · 223d
Cleared Feb 24, 1995
DATASCOPE 95 AND 97 IAB PUMP CONSOLE
K942454
Datascope Corp.
Cardiovascular · 277d
Cleared Feb 10, 1995
REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING
K935184
St. Jude Medical, Inc.
Cardiovascular · 472d
Cleared Dec 09, 1994
DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD
K944460
Datascope Corp.
Cardiovascular · 88d
Cleared Oct 14, 1994
BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER
K936232
Boston Scientific Corp
Cardiovascular · 289d
Cleared Sep 13, 1994
INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION
K940231
Datascope Corp.
Cardiovascular · 238d
Cleared Aug 09, 1994
PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION
K940178
Datascope Corp.
Cardiovascular · 209d
Cleared Dec 15, 1993
MODIFICATIONS TO INTRA-AORTIC BALLOONS
K932268
Kontron Instruments, Inc.
Cardiovascular · 259d