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 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 Aug 11, 1995
BSC/CA 30 & 40 SENSATION, MODELS 930 & 940
K952221
Boston Scientific Corp
Cardiovascular · 91d
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 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
Cleared Sep 27, 1993
MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS
K925248
Kontron Instruments, Inc.
Cardiovascular · 346d
Cleared Aug 30, 1993
9.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER
K926000
Boston Scientific Corp
Cardiovascular · 276d
Cleared Aug 25, 1993
PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON
K911000
Datascope Corp.
Cardiovascular · 901d
Cleared Aug 25, 1993
DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL
K914802
Datascope Corp.
Cardiovascular · 671d
Cleared Aug 03, 1993
PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON
K920427
Datascope Corp.
Cardiovascular · 547d
Cleared Aug 02, 1993
PEDIATRIC INTRA-AORTIC BALLOON CATHETERS
K905663
Datascope Corp.
Cardiovascular · 958d
Cleared Apr 27, 1993
SYSTEM 97
K922235
Datascope Corp.
Cardiovascular · 349d
Cleared Apr 07, 1993
BARD(R) INTRA AORTIC BALLOON
K924382
C.R. Bard, Inc.
Cardiovascular · 219d
Cleared Feb 10, 1993
SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE
K921638
Datascope Corp.
Cardiovascular · 310d
Cleared Mar 11, 1992
DATASCOPE SYSTEM 95
K912629
Datascope Corp.
Cardiovascular · 268d
Cleared Mar 11, 1992
SYSTEM 90 AND SYSTEM 90T
K913847
Datascope Corp.
Cardiovascular · 197d
Not Cleared Nov 05, 1991
DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON
K910997
Datascope Corp.
Cardiovascular · 242d