Cleared Traditional

MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP

K020147 · Medtronic Perfusion Systems · General Hospital
Apr 2002
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K020147 is an FDA 510(k) clearance for the MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Medtronic Perfusion Systems (Brooklyn Park, US). The FDA issued a Cleared decision on April 3, 2002, 77 days after receiving the submission on January 16, 2002. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K020147 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 2002
Decision Date April 03, 2002
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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