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

Substantially Equivalent

Cardiac Assist, Maquet Cardiovascular, LLC

Clearance details

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

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.