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 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 Oct 01, 1979
INTRA-AORTIC BALLOON, TYPE S
K790775
Datascope Corp.
Cardiovascular · 164d
Cleared Mar 15, 1978
BALLOON PUMP
K780280
Datascope Corp.
Cardiovascular · 22d