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
97–120 of 162
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 Apr 10, 1990
ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS
K895433
Aries Medical, Inc.
Cardiovascular · 215d
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
Cleared Mar 20, 1989
10.5 FRENCH PERCUTANEOUS DOUBLE LUMEN INTRA-AORTIC
K882274
Kontron Instruments, Inc.
Cardiovascular · 293d
Cleared Mar 20, 1989
9.5 FRENCH PERCUTANEOUS DOUBLE LUMEN BALLOON
K882508
Kontron Instruments, Inc.
Cardiovascular · 276d
Cleared Jun 10, 1988
DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL
K880289
Datascope Corp.
Cardiovascular · 137d
Cleared May 18, 1988
INTRA-AORTIC BALLOON PUMP MODEL KAAT
K875036
Kontron Instruments, Inc.
Cardiovascular · 163d
Cleared Apr 01, 1988
KONTRON INTRA-AORTIC BALLOON PUMP MODEL K2000
K874816
Kontron Instruments, Inc.
Cardiovascular · 120d
Cleared Jun 19, 1987
40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER
K864537
Aries Medical, Inc.
Cardiovascular · 214d
Cleared Jun 19, 1987
40CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETER
K864994
Aries Medical, Inc.
Cardiovascular · 179d
Cleared May 12, 1987
40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER
K864567
Aries Medical, Inc.
Cardiovascular · 174d
Cleared May 12, 1987
40CC SURGICAL DOUBLE LUMEN BALLOON CATHETER
K864568
Aries Medical, Inc.
Cardiovascular · 174d
Cleared Jan 16, 1987
40CC PERCUTANEOUS FURL SINGLE INTRA-AORTIC BALLOON
K863185
Aries Medical, Inc.
Cardiovascular · 150d