BIO-MEDICUS TUBING CONNECTORS— 510(k) K883956

Substantially Equivalent

Bio Medicus, Inc.

FDA 510(k) clearance K883956 for BIO-MEDICUS TUBING CONNECTORS, Substantially Equivalent on 1988-10-28. Applicant: Bio Medicus, Inc..

Clearance details

Applicant: Bio Medicus, Inc.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 1988-09-19
Decision date: 1988-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.