FAST-PATCH(TM)— 510(k) K871224

Substantially Equivalent

Physio-Control Corp.

FDA 510(k) clearance K871224 for FAST-PATCH(TM), Substantially Equivalent on 1987-05-20. Applicant: Physio-Control Corp..

Clearance details

Applicant: Physio-Control Corp.
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1987-03-27
Decision date: 1987-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

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Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

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.