DURACATH, GISH MODEL NO. DVAC-XXXX— 510(k) K863792

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K863792 for DURACATH, GISH MODEL NO. DVAC-XXXX, Substantially Equivalent on 1986-12-05. Applicant: Gish Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code BSO
Device class: Class 2
Regulation: 21 CFR 868.5120
Advisory panel: Anesthesiology
Date received: 1986-09-26
Decision date: 1986-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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.