ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE— 510(k) K960379

Name: FDA 510(k) clearance K960379
Creator: U.S. Food and Drug Administration
Published: 1996-04-25

Substantially Equivalent

Heart Technology Mfg., Inc.

FDA 510(k) clearance K960379 for ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE, Substantially Equivalent on 1996-04-25. Applicant: Heart Technology Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Heart Technology Mfg., Inc.
Product code: Code MCW
Device class: Class 2
Regulation: 21 CFR 870.4875
Advisory panel: Cardiovascular
Date received: 1996-01-26
Decision date: 1996-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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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.