MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730— 510(k) K091062

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K091062 for MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730, Substantially Equivalent on 2009-08-04. Applicant: Gish Biomedical, Inc..

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 2009-04-14
Decision date: 2009-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Santa Margarita, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.