PK-141 PATIENT CABLE— 510(k) K083674

Substantially Equivalent

Biotronik, Inc.

FDA 510(k) clearance K083674 for PK-141 PATIENT CABLE, Substantially Equivalent on 2009-04-01. Applicant: Biotronik, Inc..

Clearance details

Applicant: Biotronik, Inc.
Product code: Code DTC
Advisory panel: Cardiovascular
Date received: 2008-12-11
Decision date: 2009-04-01
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.