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 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
Cleared Sep 25, 1990
PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG
K902057
Datascope Corp.
Cardiovascular · 141d
Cleared Sep 14, 1990
9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON
K892222
Kontron Instruments, Inc.
Cardiovascular · 529d
Cleared Aug 17, 1990
PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON
K896497
Datascope Corp.
Cardiovascular · 276d
Cleared Apr 19, 1990
SERIES 3001 IABP
K900281
Boston Scientific Corp
Cardiovascular · 87d
Cleared Mar 06, 1990
SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER
K896920
Boston Scientific Corp
Cardiovascular · 84d
Cleared Feb 12, 1990
THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH.
K896597
Boston Scientific Corp
Cardiovascular · 83d
Cleared Feb 05, 1990
PERCOR STAT-DL 9.5 FR & STAT-SL 8.5 FR INTRA-AORTI
K896430
Datascope Corp.
Cardiovascular · 89d
Cleared Sep 26, 1989
SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER
K894942
Boston Scientific Corp
Cardiovascular · 54d
Cleared Sep 20, 1989
10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON
K892797
Kontron Instruments, Inc.
Cardiovascular · 156d
Cleared Sep 20, 1989
9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON
K892798
Kontron Instruments, Inc.
Cardiovascular · 156d
Cleared Sep 20, 1989
8 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON
K892799
Kontron Instruments, Inc.
Cardiovascular · 156d
Cleared Sep 13, 1989
KONTRON INTRA-AORTIC BALLOON PUMP MODEL K9000
K892878
Kontron Instruments, Inc.
Cardiovascular · 147d
Cleared Jun 20, 1989
INTRA AORTIC BALLOON
K893243
Datascope Corp.
Cardiovascular · 19d