DISPOSABLE CORONARY CONTROL SYRINGE— 510(k) K902346

Name: FDA 510(k) clearance K902346
Creator: U.S. Food and Drug Administration
Published: 1990-06-26

Substantially Equivalent

Advance Medical Designs, Inc.

FDA 510(k) clearance K902346 for DISPOSABLE CORONARY CONTROL SYRINGE, Substantially Equivalent on 1990-06-26. Applicant: Advance Medical Designs, Inc.. Device class: 2.

Clearance details

Applicant: Advance Medical Designs, Inc.
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 1990-05-25
Decision date: 1990-06-26
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 FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.