ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK— 510(k) K915301

Name: FDA 510(k) clearance K915301
Creator: U.S. Food and Drug Administration
Published: 1992-12-11

Substantially Equivalent

Advance Medical Designs, Inc.

FDA 510(k) clearance K915301 for ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK, Substantially Equivalent on 1992-12-11. Applicant: Advance Medical Designs, Inc.. Device class: 2.

Clearance details

Applicant: Advance Medical Designs, Inc.
Product code: Code DTL
Device class: Class 2
Regulation: 21 CFR 870.4290
Advisory panel: Cardiovascular
Date received: 1991-11-21
Decision date: 1992-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

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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.