Cleared Traditional

K943349 - MAHURKAR DUAL LUMEN CATHETER
(FDA 510(k) Clearance)

K943349 · Quinton, Inc. · General Hospital

Mar 1995

Decision

253d

Days

Class 2

Risk

K943349 is an FDA 510(k) clearance for the MAHURKAR DUAL LUMEN CATHETER. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ).

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on March 22, 1995, 253 days after receiving the submission on July 12, 1994.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K943349 FDA.gov
FDA Decision	Cleared SESK
Date Received	July 12, 1994
Decision Date	March 22, 1995
Days to Decision	253 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200