DSP · Class II · 21 CFR 870.3535

FDA Product Code DSP: System, Balloon, Intra-aortic And Control

Leading manufacturers include Boston Scientific Corp, C.R. Bard, Inc. and Arrow International, Inc..

162
Total
161
Cleared
171d
Avg days
1976
Since
162 devices
25–48 of 162
Cleared Apr 07, 1993
BARD(R) INTRA AORTIC BALLOON
K924382
C.R. Bard, Inc.
Cardiovascular · 219d
Cleared Apr 19, 1990
SERIES 3001 IABP
K900281
Boston Scientific Corp
Cardiovascular · 87d
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 Sep 26, 1989
SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER
K894942
Boston Scientific Corp
Cardiovascular · 54d