CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX— 510(k) K031636

Clearance details

Applicant

Datascope Corp.

Product code

Code DSP

Device class

Class 2

Regulation

21 CFR 870.3535

Advisory panel

Cardiovascular

Date received

2003-05-27

Decision date

2003-08-11

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Mahwh, NJ, US

• K250542 — AC3 Range Intra-Aortic Balloon Pump2025-03-26
• K232343 — AC3 Series IABP2023-08-30
• K201112 — AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP2020-05-27
• K200634 — Arrow FiberOptix Intra-Aortic Balloon Catheter Kit2020-04-09
• K192238 — AC3 Series Intra-Aortic Balloon Pump (IABP)2019-11-12

• K190884 — TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool2019-12-26
• K181122 — CARDIOSAVE Intra-Aortic Balloon Pump2018-05-31
• K172305 — CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump2017-10-12
• K163542 — CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case2017-01-31
• K151254 — CARDIOSAVE Hybrid Intra-Aortic Balloon Pump2015-07-02

Death

317

Injury

566

Malfunction

36,831

Other

4

Total

37,718

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1486-2026 — CS100 IABP. Software Version CS100 IABP Q.01.Class II·Ongoing·Datascope Corp.·20260123
• Z-3085-2017 — CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.Class I·Ongoing·Maquet Datascope Corp - Cardiac Assist Division·20170717
• Z-3086-2017 — CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.Class I·Ongoing·Maquet Datascope Corp - Cardiac Assist Division·20170717
• Z-2736-2017 — CS 100i Intra-Aortic Balloon PumpClass I·Terminated·Maquet Datascope Corp - Cardiac Assist Division·20170616
• Z-2737-2017 — CS 100 Intra-Aortic Balloon PumpClass I·Terminated·Maquet Datascope Corp - Cardiac Assist Division·20170616
• Z-1523-2014 — Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.Class I·Terminated·Maquet Datascope Corp - Cardiac Assist Division·20140321

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031636.