DUAL LUMEN NEEDLE (PRODUCT CHANGE)— 510(k) K860515

Name: FDA 510(k) clearance K860515
Creator: U.S. Food and Drug Administration
Published: 1986-03-04

Substantially Equivalent

Quinton, Inc.

FDA 510(k) clearance K860515 for DUAL LUMEN NEEDLE (PRODUCT CHANGE), Substantially Equivalent on 1986-03-04. 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: 1986-02-11
Decision date: 1986-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LBW

view all

K904433 — DUAL LUMEN NEEDLES1990-11-23
K864629 — MODIFIED DUAL LUMEN NEEDLE1986-12-16
K820859 — COAXIAL DUAL FLOW CATHETER1982-04-16
K801968 — HEMOCATH I KIDNEY DIALYSIS CATHETER1980-09-26

More clearances from Quinton, Inc.

view all

K032038 — PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 926012003-09-05
K021906 — QUINTON Q-CATH, MODEL 0004602002-09-04
K003576 — Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 0005032001-01-25
K001492 — QUINTON Q-STRESS, MODEL 0004832000-08-09
K992908 — Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)2000-03-06

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