Cleared Traditional

POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS

K100432 · Medtronic Minimed · General Hospital
Jul 2010
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K100432 is an FDA 510(k) clearance for the POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on July 9, 2010, 143 days after receiving the submission on February 16, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K100432 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2010
Decision Date July 09, 2010
Days to Decision 143 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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