DISPOSABLE HEMOSTATIC Y-CONNECTORS— 510(k) K113132

Substantially Equivalent

Coeur, Inc.

FDA 510(k) clearance K113132 for DISPOSABLE HEMOSTATIC Y-CONNECTORS, Substantially Equivalent on 2012-01-20. Applicant: Coeur, Inc..

Clearance details

Applicant: Coeur, Inc.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 2011-10-24
Decision date: 2012-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lebanon, TN, 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.