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
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
Cleared
Mar 26, 2025
AC3™ Range™ Intra-Aortic Balloon Pump
Arrow International, LLC
Cardiovascular
30d
Cleared
Aug 30, 2023
AC3™ Series IABP
Arrow International, LLC
Cardiovascular
26d
Cleared
May 27, 2020
AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
Arrow International, Inc.
Cardiovascular
30d
Cleared
Apr 09, 2020
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
Arrow International, Inc.
Cardiovascular
30d
Cleared
Nov 12, 2019
AC3 Series Intra-Aortic Balloon Pump (IABP)
Arrow International, Teleflex
Cardiovascular
85d
Cleared
Jun 28, 2019
UltraFlex IAB
Arrow International, Inc.
Cardiovascular
157d
Cleared
Jun 13, 2019
Fiberoptix IAB
Arrow International, Inc.
Cardiovascular
140d
Cleared
May 31, 2018
CARDIOSAVE Intra-Aortic Balloon Pump
Datascope Corp.
Cardiovascular
31d
Cleared
Oct 12, 2017
CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
Datascope Corp.
Cardiovascular
73d
Cleared
Jan 31, 2017
CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
Datascope Corp.
Cardiovascular
46d
Cleared
Jul 02, 2015
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
Datascope Corp.
Cardiovascular
51d
Cleared
Dec 12, 2013
MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES
Datascope Corp.
Cardiovascular
73d
Cleared
Jan 05, 2007
DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM
Datascope Corp.
Cardiovascular
44d
Cleared
Apr 06, 2006
AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES
Arrow Intl., Inc.
Cardiovascular
58d
Cleared
Jun 07, 2004
DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
Datascope Corp.
Cardiovascular
25d
Cleared
May 06, 2004
INTRA-AORTIC BALLOON (IAB)
Arrow Intl., Inc.
Cardiovascular
38d
Cleared
Aug 11, 2003
CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
Datascope Corp.
Cardiovascular
76d
Cleared
Jun 10, 2003
DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX
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
Arrow Intl., Inc.
Cardiovascular
30d
Cleared
Apr 24, 2002
DATASCOPE'S 8FR. ALT B IAB
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
Datascope Corp.
Cardiovascular
28d
Cleared
May 03, 2001
ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
Arrow Intl., Inc.
Cardiovascular
282d
Cleared
Mar 02, 2001
ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U
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
Datascope Corp.
Cardiovascular
30d
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 →