K120868

Substantially Equivalent

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

Applicant: Datascope Corp., Cardiac Assist Division
Product code: DSP
Advisory panel: Cardiovascular
Date received: 2012-03-22
Decision date: 2012-04-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Fairfield, 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.