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
121–144 of 162
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
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 09, 1986
MONARK 869 ERGOMETER
K855102
Equilibrated Bio Systems, Inc.
Cardiovascular · 137d
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 Dec 11, 1985
PRESSURE TRIGGER MOD OF SMEC INTRA-AORT
K840367
Smec, Inc.
Cardiovascular · 684d
Cleared Aug 22, 1985
DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO
K850482
Datascope Corp.
Cardiovascular · 196d
Cleared Feb 20, 1985
ARIES MEDICAL PERFLEX PERCUTANEOUS 40CC D/L BALLOO
K844220
Aries Medical, Inc.
Cardiovascular · 112d
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 Feb 01, 1985
MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC
K840037
Smec, Inc.
Cardiovascular · 393d
Cleared Oct 13, 1984
PERCUTANEOUS BALLOON
K832753
Smec, Inc.
Cardiovascular · 425d
Cleared May 16, 1984
ARIES MEDICAL MODEL 700
K833632
Aries Medical, Inc.
Cardiovascular · 212d
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 Feb 18, 1983
INTRA-AORTIC BALLOON SYSTEM
K823739
Smec, Inc.
Cardiovascular · 67d
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 Dec 15, 1982
SMEC BALLOON SYSTEM
K823177
Smec, Inc.
Cardiovascular · 50d