Cleared Traditional

MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1

K052431 · Medtronic Minimed · General Hospital
Nov 2005
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K052431 is an FDA 510(k) clearance for the MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1, a Tubing, Fluid Delivery (Class II — Special Controls, product code FPK), 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 K052431 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 FPK — Tubing, Fluid Delivery
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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