MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004— 510(k) K882429

Substantially Equivalent

Tpl-Cordis, Inc.

FDA 510(k) clearance K882429 for MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004, Substantially Equivalent on 1988-07-22. Applicant: Tpl-Cordis, Inc..

Clearance details

Applicant: Tpl-Cordis, Inc.
Product code: Code KRG
Advisory panel: Cardiovascular
Date received: 1988-06-14
Decision date: 1988-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

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Adverse events under product code KRG

product code KRG

Malfunction: 8,377
Total: 8,377

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.