MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER— 510(k) K120868

Name: FDA 510(k) clearance K120868
Creator: U.S. Food and Drug Administration
Published: 2012-04-20

Substantially Equivalent

Datascope Corp., Cardiac Assist Division

FDA 510(k) clearance K120868 for MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER, Substantially Equivalent on 2012-04-20. Applicant: Datascope Corp., Cardiac Assist Division. Device class: 2.

Clearance details

Applicant: Datascope Corp., Cardiac Assist Division
Product code: Code DSP
Device class: Class 2
Regulation: 21 CFR 870.3535
Advisory panel: Cardiovascular
Date received: 2012-03-22
Decision date: 2012-04-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Fairfield, NJ, US

Download summary PDF View on FDA.gov ↗

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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

More clearances from Datascope Corp., Cardiac Assist Division

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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 K120868

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120868.

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