ROTABLATOR, MODIFICATION— 510(k) K933238

Name: FDA 510(k) clearance K933238
Creator: U.S. Food and Drug Administration
Published: 1993-08-24

Substantially Equivalent

Heart Technology, Inc.

FDA 510(k) clearance K933238 for ROTABLATOR, MODIFICATION, Substantially Equivalent on 1993-08-24. Applicant: Heart Technology, Inc.. Device class: 2.

Clearance details

Applicant: Heart Technology, Inc.
Product code: Code MCW
Device class: Class 2
Regulation: 21 CFR 870.4875
Advisory panel: Cardiovascular
Date received: 1993-06-15
Decision date: 1993-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

Download summary PDF View on FDA.gov ↗

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K914581 — HEART TECHNOLOGY WIRECLIP1992-01-06
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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.