HEART TECHNOLOGY ROTABLATOR WIRECLIP— 510(k) K913450

Substantially Equivalent

Heart Technology, Inc.

FDA 510(k) clearance K913450 for HEART TECHNOLOGY ROTABLATOR WIRECLIP, Substantially Equivalent on 1991-09-06. Applicant: Heart Technology, Inc..

Clearance details

Applicant: Heart Technology, Inc.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 1991-08-02
Decision date: 1991-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

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Adverse events under product code MCW

product code MCW

Death: 38
Injury: 1,386
Malfunction: 2,676
Other: 2
Total: 4,102

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.