MODEL 4280 SURGICAL EXTENSION CABLE— 510(k) K922899

Substantially Equivalent

Pace Medical

FDA 510(k) clearance K922899 for MODEL 4280 SURGICAL EXTENSION CABLE, Substantially Equivalent on 1992-12-23. Applicant: Pace Medical.

Clearance details

Applicant: Pace Medical
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 1992-06-16
Decision date: 1992-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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.