GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING— 510(k) K082082

Name: FDA 510(k) clearance K082082
Creator: U.S. Food and Drug Administration
Published: 2009-02-04

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K082082 for GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING, Substantially Equivalent on 2009-02-04. Applicant: Gish Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code DTN
Device class: Class 2
Regulation: 21 CFR 870.4400
Advisory panel: Cardiovascular
Date received: 2008-07-23
Decision date: 2009-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Santa Margarita, CA, US

Download summary PDF View on FDA.gov ↗

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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.