PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE— 510(k) K901332

Substantially Equivalent

Biotronik, GmbH & Co.

FDA 510(k) clearance K901332 for PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE, Substantially Equivalent on 1990-05-09. Applicant: Biotronik, GmbH & Co..

Clearance details

Applicant: Biotronik, GmbH & Co.
Product code: Code DTC
Advisory panel: Cardiovascular
Date received: 1990-03-22
Decision date: 1990-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Oswego, OR, US

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Adverse events under product code DTC

product code DTC

Injury: 136
Malfunction: 3,400
Total: 3,536

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.