NON-STERILE SHADOW-STRIPE CATHETER— 510(k) K812717

Name: FDA 510(k) clearance K812717
Creator: U.S. Food and Drug Administration
Published: 1981-10-19

Substantially Equivalent

Quinton, Inc.

FDA 510(k) clearance K812717 for NON-STERILE SHADOW-STRIPE CATHETER, Substantially Equivalent on 1981-10-19. Applicant: Quinton, Inc.. Device class: 2.

Clearance details

Applicant: Quinton, Inc.
Product code: Code FKO
Device class: Class 2
Regulation: 21 CFR 876.5630
Advisory panel: Gastroenterology, Urology
Date received: 1981-09-25
Decision date: 1981-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FKO

product code FKO

Other: 1
Total: 1

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.