Cleared Traditional

Q-PORT SYSTEM KIT

K894650 · Quinton, Inc. · General Hospital
Mar 1990
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K894650 is an FDA 510(k) clearance for the Q-PORT SYSTEM KIT, a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II — Special Controls, product code LJT), submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on March 12, 1990, 231 days after receiving the submission on July 24, 1989. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K894650 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1989
Decision Date March 12, 1990
Days to Decision 231 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5965

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