TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528— 510(k) K001180

Substantially Equivalent

Pace Medical

FDA 510(k) clearance K001180 for TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528, Substantially Equivalent on 2000-06-27. Applicant: Pace Medical.

Clearance details

Applicant: Pace Medical
Product code: Code DTE
Advisory panel: Cardiovascular
Date received: 2000-04-11
Decision date: 2000-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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Adverse events under product code DTE

product code DTE

Death: 18
Injury: 247
Malfunction: 4,603
Total: 4,868

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.