K910845

Substantially Equivalent

ITC ROTATING HEMOSTATIC VALVE CAT. NO. MX 1012

Applicant: Interventional Therapeutics Corp.
Product code: DTL
Advisory panel: Cardiovascular
Date received: 1991-02-27
Decision date: 1991-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Francisco, CA, US

Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.