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

Name: FDA 510(k) clearance K910845
Creator: U.S. Food and Drug Administration
Published: 1991-05-21

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.. Device class: 2.

Clearance details

Applicant: Interventional Therapeutics Corp.
Product code: Code DTL
Device class: Class 2
Regulation: 21 CFR 870.4290
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

Download summary PDF View on FDA.gov ↗

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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.