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
145–162 of 162
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 Jul 02, 1982
MODIFICATION OF THE PERCUTAN-BALLOON
K813355
Smec, Inc.
Cardiovascular · 217d
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 Dec 02, 1981
FUKUDA DENSHI CARDIMAX FK-11
K813023
Brentwood Instruments, Inc.
Cardiovascular · 36d
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
Cleared Mar 11, 1981
KONTRON PERCUTAEOUS DOUBLE-LUMEN
K802924
Avco Medical Products
Cardiovascular · 113d
Cleared Jan 13, 1981
DATASCOPE/AVCO CONNECTOR
K801601
Datascope Corp.
Cardiovascular · 183d
Cleared Jan 13, 1981
PERCOR DATASCOPE INTRA-AORTIC BALLOON
K802167
Datascope Corp.
Cardiovascular · 127d
Cleared May 14, 1980
SMEC BALLOON CANNULA
K790755
Smec, Inc.
Cardiovascular · 393d
Cleared Oct 01, 1979
INTRA-AORTIC BALLOON, TYPE S
K790775
Datascope Corp.
Cardiovascular · 164d
Cleared Feb 23, 1979
INTRA-AORTIC BALLOON-PUMP
K790241
Avco Medical Products
Cardiovascular · 22d
Cleared Jan 23, 1979
PUMP, BALLOON MODEL 10
K781848
Avco Medical Products
Cardiovascular · 92d
Cleared Mar 15, 1978
BALLOON PUMP
K780280
Datascope Corp.
Cardiovascular · 22d
Cleared May 06, 1977
PUMP, BALLOON, INTRA-AORTIC, TRI-SEGMENT
K770821
Avco Medical Products
Cardiovascular · 2d
Cleared Oct 06, 1976
TAMARI-KAPLITT
K760695
Yehuda Tamari
Cardiovascular · 16d