SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES— 510(k) K112327

Name: FDA 510(k) clearance K112327
Creator: U.S. Food and Drug Administration
Published: 2011-09-09

Substantially Equivalent

Cardiac Assist, Maquet Cardiovascular, LLC

FDA 510(k) clearance K112327 for SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, Substantially Equivalent on 2011-09-09. Applicant: Cardiac Assist, Maquet Cardiovascular, LLC. Device class: 2.

Clearance details

Applicant: Cardiac Assist, Maquet Cardiovascular, LLC
Product code: Code DSP
Device class: Class 2
Regulation: 21 CFR 870.3535
Advisory panel: Cardiovascular
Date received: 2011-08-12
Decision date: 2011-09-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Manwah, NJ, US

Download summary PDF View on FDA.gov ↗

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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

More clearances from Cardiac Assist, Maquet Cardiovascular, LLC

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K112372 — CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP2011-09-15

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 →

Recalls naming K112327

K-number listed on FDA's recall record

Z-0311-2025 — MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01Class II·Ongoing·Datascope Corp.·20240917

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112327.

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