CATALYST II AND III— 510(k) K130124

Substantially Equivalent

Cardiva Medical, Inc.

FDA 510(k) clearance K130124 for CATALYST II AND III, Substantially Equivalent on 2013-03-14. Applicant: Cardiva Medical, Inc..

Clearance details

Applicant: Cardiva Medical, Inc.
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2013-01-17
Decision date: 2013-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orinda, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.