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
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 30d recently vs 171d historically

FDA 510(k) Cleared System, Balloon, Intra-aortic And Control Devices (Product Code DSP)

162 devices
1–24 of 162
Cleared Mar 26, 2025
AC3™ Range™ Intra-Aortic Balloon Pump
K250542
Arrow International, LLC
Cardiovascular · 30d
Cleared Aug 30, 2023
AC3™ Series IABP
K232343
Arrow International, LLC
Cardiovascular · 26d
Cleared May 27, 2020
AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
K201112
Arrow International, Inc.
Cardiovascular · 30d
Cleared Apr 09, 2020
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
K200634
Arrow International, Inc.
Cardiovascular · 30d
Cleared Nov 12, 2019
AC3 Series Intra-Aortic Balloon Pump (IABP)
K192238
Arrow International, Teleflex
Cardiovascular · 85d
Cleared Jun 28, 2019
UltraFlex IAB
K190101
Arrow International, Inc.
Cardiovascular · 157d
Cleared Jun 13, 2019
Fiberoptix IAB
K190117
Arrow International, Inc.
Cardiovascular · 140d
Cleared May 31, 2018
CARDIOSAVE Intra-Aortic Balloon Pump
K181122
Datascope Corp.
Cardiovascular · 31d
Cleared Oct 12, 2017
CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
K172305
Datascope Corp.
Cardiovascular · 73d
Cleared Jan 31, 2017
CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
K163542
Datascope Corp.
Cardiovascular · 46d
Cleared Oct 16, 1998
Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters
K981660
C.R. Bard, Inc.
Cardiovascular · 158d
Cleared Jun 03, 1998
BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS
K980850
C.R. Bard, Inc.
Cardiovascular · 90d
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 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
Cleared Nov 04, 1996
MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C
K963187
Boston Scientific Corp
Cardiovascular · 82d
Cleared Sep 04, 1996
BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT
K962177
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Jan 11, 1996
PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS
K954431
Boston Scientific Corp
Cardiovascular · 108d
Cleared Aug 11, 1995
BSC/CA 30 & 40 SENSATION, MODELS 930 & 940
K952221
Boston Scientific Corp
Cardiovascular · 91d
Cleared Apr 06, 1995
BSC/CA MODEL 940 IAB
K940298
Boston Scientific Corp
Cardiovascular · 440d
Cleared Mar 23, 1995
9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER
K943919
Boston Scientific Corp
Cardiovascular · 223d
Cleared Oct 14, 1994
BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER
K936232
Boston Scientific Corp
Cardiovascular · 289d
Cleared Aug 30, 1993
9.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER
K926000
Boston Scientific Corp
Cardiovascular · 276d

About Product Code DSP - Regulatory Context

510(k) Submission Activity

162 total 510(k) submissions under product code DSP since 1976, with 161 receiving FDA clearance (average review time: 171 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - DSP Product Code

Recent submissions under DSP have taken an average of 30 days to reach a decision - down from 171 days historically, suggesting improved FDA processing for this classification.

DSP devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →