ITC ROTATING HEMOSTATIC VALVE CAT. NO. MX 1012— 510(k) K910845

Substantially Equivalent

Interventional Therapeutics Corp.

FDA 510(k) clearance K910845 for ITC ROTATING HEMOSTATIC VALVE CAT. NO. MX 1012, Substantially Equivalent on 1991-05-21. Applicant: Interventional Therapeutics Corp..

Clearance details

Applicant: Interventional Therapeutics Corp.
Product code: 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

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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.