MODIFIED DUAL LUMEN NEEDLE— 510(k) K864629

Substantially Equivalent

Quinton, Inc.

FDA 510(k) clearance K864629 for MODIFIED DUAL LUMEN NEEDLE, Substantially Equivalent on 1986-12-16. Applicant: Quinton, Inc.. Device class: 2.

Clearance details

Applicant: Quinton, Inc.
Product code: Code LBW
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 1986-11-25
Decision date: 1986-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LBW

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K820859 — COAXIAL DUAL FLOW CATHETER1982-04-16
K801968 — HEMOCATH I KIDNEY DIALYSIS CATHETER1980-09-26

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Data sourced from openFDA. This site is unofficial and independent of the FDA.