K003598

Substantially Equivalent

DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320

Applicant: Datascope Corp.
Product code: DSP
Advisory panel: Cardiovascular
Date received: 2000-11-21
Decision date: 2000-12-21
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.