AC3 Series Intra-Aortic Balloon Pump (IABP)— 510(k) K192238

Name: FDA 510(k) clearance K192238
Creator: U.S. Food and Drug Administration
Published: 2019-11-12

Substantially Equivalent

Arrow International, Teleflex

FDA 510(k) clearance K192238 for AC3 Series Intra-Aortic Balloon Pump (IABP), Substantially Equivalent on 2019-11-12. Applicant: Arrow International, Teleflex. Device class: 2.

Clearance details

Applicant: Arrow International, Teleflex
Product code: Code DSP
Device class: Class 2
Regulation: 21 CFR 870.3535
Advisory panel: Cardiovascular
Date received: 2019-08-19
Decision date: 2019-11-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Chelmsford, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSP

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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
K190101 — UltraFlex IAB2019-06-28

Adverse events under product code DSP

product code DSP

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.