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
73–96 of 162
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 Oct 30, 1992
BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP
K915580
Belmont Instrument Corp.
Cardiovascular · 339d
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
Cleared Jun 19, 1991
KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II
K905313
Kontron Instruments, Inc.
Cardiovascular · 203d
Cleared Jun 11, 1991
PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT
K905056
Datascope Corp.
Cardiovascular · 215d
Cleared Jan 15, 1991
9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)
K903344
Kontron Instruments, Inc.
Cardiovascular · 174d
Cleared Nov 16, 1990
DATASCOPE PERCOR STAT DL 10.5 FR 50CC
K903930
Datascope Corp.
Cardiovascular · 84d
Cleared Oct 22, 1990
DATASCOPE PERCOR STAT DL 9.5 FR40CC STERIL ETO GAS
K904414
Datascope Corp.
Cardiovascular · 63d
Cleared Oct 19, 1990
PERCOR STAT DL 9.5 FR 34CC INTRA-AORTIC BALLOON
K903769
Datascope Corp.
Cardiovascular · 60d
Cleared Oct 19, 1990
DATASCOPE PERCOR STAT DL 10.5 FR 40CC
K903867
Datascope Corp.
Cardiovascular · 58d
Cleared Oct 19, 1990
DATASCOPE PERCOR STAT 8.5 FR 40CC INTRA-AORTIC BAL
K903892
Datascope Corp.
Cardiovascular · 58d
Cleared Oct 19, 1990
DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL
K903893
Datascope Corp.
Cardiovascular · 58d
Cleared Oct 19, 1990
DATASCOPE PERCOR STAT DL 9.5 FR 40CC INTRA-AOR BAL
K904018
Datascope Corp.
Cardiovascular · 50d
Cleared Oct 09, 1990
DATASCOPE PERCOR STAT DL10.5 FR40CC IN AORTIC BAL
K903736
Datascope Corp.
Cardiovascular · 54d