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 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 Jan 14, 1987
SYSTEM 90 TRANSPORT
K863219
Datascope Corp.
Cardiovascular · 147d
Cleared Oct 01, 1986
NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON
K860638
Kontron Instruments, Inc.
Cardiovascular · 223d
Cleared May 07, 1986
KONTRON INTRA-AORTIC BALLOON PUMP MODEL KAAT
K860427
Kontron Instruments, Inc.
Cardiovascular · 92d
Cleared Jan 22, 1986
INTRA-AORTIC BALLOON PUMP MODEL K2000
K853062
Kontron Instruments, Inc.
Cardiovascular · 187d
Cleared Aug 22, 1985
DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO
K850482
Datascope Corp.
Cardiovascular · 196d
Cleared Feb 08, 1985
IABP #90 SYSTEM
K831235
Datascope Corp.
Cardiovascular · 665d
Cleared Feb 08, 1985
PERCOR 9.5 FR IAB ON DATASCOPE CO2
K833828
Datascope Corp.
Cardiovascular · 464d
Cleared Nov 02, 1983
PECOR 8.5 FRENCH IAB ON A DATASCOPE
K831307
Datascope Corp.
Cardiovascular · 194d
Cleared Nov 02, 1983
FRENCH INTRA-AORTIC 9.5 BALLOON ON KON
K831397
Datascope Corp.
Cardiovascular · 187d
Cleared Apr 27, 1983
EK COMBI MSG-1
K830410
Jedmed Instrument Co.
Cardiovascular · 78d
Cleared Apr 27, 1983
MINISCOPE MS-2
K830411
Jedmed Instrument Co.
Cardiovascular · 78d
Cleared Jan 24, 1983
PERCOR INTRA-AORTIC BALLOON INSERTION
K823342
Datascope Corp.
Cardiovascular · 77d
Cleared Dec 21, 1982
DATASCOPE MODEL 83 IABP SYSTEM
K821951
Datascope Corp.
Cardiovascular · 174d
Cleared Oct 18, 1982
PECOR, PERCOR-DL, 10.5 FRENCH W/SMEC
K820882
Datascope Corp.
Cardiovascular · 202d
Cleared Aug 19, 1982
DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL
K821065
Datascope Corp.
Cardiovascular · 126d
Cleared Apr 29, 1982
ADAPTATION OF KANTRON 40 CC. PDLIAB
K820166
Kontron Instruments, Inc.
Cardiovascular · 98d
Cleared Mar 31, 1982
DATASCOPE MODIFIED #82 IABP SYSTEM
K813182
Datascope Corp.
Cardiovascular · 139d
Cleared Aug 03, 1981
MODEL 84 TRANSPORT SYSTEM
K811372
Datascope Corp.
Cardiovascular · 80d
Cleared May 06, 1981
DATASCOPE PERCOR=DL DUAL-LUMEN INTRA
K810297
Datascope Corp.
Cardiovascular · 90d