Cleared Traditional

MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2

K052432 · Medtronic Minimed · General Hospital
Nov 2005
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K052432 is an FDA 510(k) clearance for the MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on November 29, 2005, 84 days after receiving the submission on September 6, 2005. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K052432 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2005
Decision Date November 29, 2005
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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