GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING— 510(k) K081947

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K081947 for GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING, Substantially Equivalent on 2009-02-04. Applicant: Gish Biomedical, Inc..

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 2008-07-08
Decision date: 2009-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

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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.