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
25–48 of 162
Cleared Jun 10, 2003
DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX
K031569
Datascope Corp.
Cardiovascular · 21d
Cleared Jun 06, 2002
ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840
K021462
Arrow Intl., Inc.
Cardiovascular · 30d
Cleared Apr 24, 2002
DATASCOPE'S 8FR. ALT B IAB
K020257
Datascope Corp.
Cardiovascular · 90d
Cleared Nov 02, 2001
MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B
K013326
Datascope Corp.
Cardiovascular · 28d
Cleared May 03, 2001
ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
K002256
Arrow Intl., Inc.
Cardiovascular · 282d
Cleared Mar 02, 2001
ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U
K010330
Arrow Intl., Inc.
Cardiovascular · 28d
Cleared Dec 21, 2000
DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320
K003598
Datascope Corp.
Cardiovascular · 30d
Cleared Oct 20, 2000
MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC
K002949
Datascope Corp.
Cardiovascular · 29d
Cleared May 19, 2000
ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
K000729
Arrow Intl., Inc.
Cardiovascular · 74d
Cleared Mar 13, 2000
DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329
K994157
Datascope Corp.
Cardiovascular · 95d
Cleared Feb 18, 2000
8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER
K993966
Arrow Intl., Inc.
Cardiovascular · 87d
Cleared Jan 06, 2000
BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP
K983866
Belmont Instrument Corp.
Cardiovascular · 430d
Cleared Oct 16, 1998
Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters
K981660
C.R. Bard, Inc.
Cardiovascular · 158d
Cleared Oct 02, 1998
BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP
K982538
Belmont Instrument Corp.
Cardiovascular · 73d
Cleared Jun 04, 1998
IAB-04840-U
K970689
Arrow Intl., Inc.
Cardiovascular · 464d
Cleared Jun 03, 1998
BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS
K980850
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared May 29, 1998
DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES
K980780
Datascope Corp.
Cardiovascular · 88d
Cleared May 01, 1998
DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES
K980385
Datascope Corp.
Cardiovascular · 88d
Cleared Feb 19, 1998
BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS
K973962
C.R. Bard, Inc.
Cardiovascular · 126d
Cleared Feb 10, 1998
40 CC GRANDE
K974247
Boston Scientific Corp
Cardiovascular · 90d
Cleared Jan 23, 1998
ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)
K965209
Arrow Intl., Inc.
Cardiovascular · 392d
Cleared Sep 16, 1997
8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S
K963865
Arrow Intl., Inc.
Cardiovascular · 357d
Cleared Sep 02, 1997
30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL
K972113
Boston Scientific Corp
Cardiovascular · 89d
Cleared Aug 05, 1997
40 CC SUMO
K971673
Boston Scientific Corp
Cardiovascular · 90d