HEART TECHNOLOGY WIRECLIP— 510(k) K914581

Name: FDA 510(k) clearance K914581
Creator: U.S. Food and Drug Administration
Published: 1992-01-06

Substantially Equivalent

Heart Technology, Inc.

FDA 510(k) clearance K914581 for HEART TECHNOLOGY WIRECLIP, Substantially Equivalent on 1992-01-06. Applicant: Heart Technology, Inc.. Device class: 2.

Clearance details

Applicant: Heart Technology, Inc.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 1991-10-16
Decision date: 1992-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Heart Technology, Inc.

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K933238 — ROTABLATOR, MODIFICATION1993-08-24
K913450 — HEART TECHNOLOGY ROTABLATOR WIRECLIP1991-09-06
K901206 — ROTABLATOR1990-09-14

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.