DJP UNIPOLAR— 510(k) K853567

Substantially Equivalent

Biotronik Sales, Inc.

FDA 510(k) clearance K853567 for DJP UNIPOLAR, Substantially Equivalent on 1986-05-07. Applicant: Biotronik Sales, Inc..

Clearance details

Applicant: Biotronik Sales, Inc.
Product code: Code DTB
Advisory panel: Cardiovascular
Date received: 1985-08-26
Decision date: 1986-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Oswego, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTB

product code DTB

Death: 1,491
Injury: 67,311
Malfunction: 79,368
Other: 10
Total: 148,180

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.