DSPClass II

System, Balloon, Intra-Aortic And Control

21 CFR 870.3535 / Cardiovascular

DSP is the FDA product code for System, Balloon, Intra-Aortic And Control, a class II device type, regulated under 21 CFR 870.3535. As of 2026-09-10, FDA records hold 162 510(k) clearances under this code, the most recent dated 2025-03-26, and 194 recalls.

Classification record

Product code: DSP
Device name: System, Balloon, Intra-Aortic And Control
Regulation: 21 CFR 870.3535
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 162
Ingested recalls: 194

Clearances, product code DSP

By decision year

162 clearances under product code DSP with a decision year between 1976 and 2025, 1990 the highest year at 16.

Show the numbers

510(k) clearances under FDA product code DSP by decision year
Year	Clearances
1976	1
1977	1
1978	1
1979	3
1980	1
1981	6
1982	7
1983	6
1984	2
1985	6
1986	4
1987	6
1988	3
1989	8
1990	16
1991	5
1992	3
1993	10
1994	4
1995	8
1996	7
1997	7
1998	9
2000	6
2001	3
2002	2
2003	2
2004	2
2006	2
2007	2
2009	2
2011	2
2012	2
2013	1
2015	1
2017	3
2018	1
2019	3
2020	2
2023	1
2025	1

Applicants with the most clearances

Product code DSP

Applicants holding the most 510(k) clearances under product code DSP
Applicant	Clearances
Datascope Corp.	64
Kontron Instruments, Inc.	17
Arrow Intl., Inc.	15
Boston Scientific Corporation	14
Aries Medical, Inc.	8
Arrow International LLC (subsidiary of Teleflex Incorporated)	7
Belmont Medical Technologies	5
C.R. Bard Inc	5
Smec, Inc.	5
Avco Medical Products	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order