510(k) K972500— TIR/TIJ AND POLYROX

Substantially Equivalent - Subject to Tracking & PMS

Biotronik, Inc.

Clearance details

Applicant: Biotronik, Inc.
Product code: Code DTB
Advisory panel: Cardiovascular
Date received: 1997-07-03
Decision date: 1998-03-04
Decision: Substantially Equivalent - Subject to Tracking & PMS
Clearance type: Traditional
Location: Lake Oswego, OR, US

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.