Cleared Traditional

Extended Reservoir

K210714 · Medtronic Minimed, Inc. · Chemistry
Apr 2022
Decision
392d
Days
Class 2
Risk

About This 510(k) Submission

K210714 is an FDA 510(k) clearance for the Extended Reservoir, a Pump, Infusion, Insulin (Class II — Special Controls, product code LZG), submitted by Medtronic Minimed, Inc. (Northridge, US). The FDA issued a Cleared decision on April 6, 2022, 392 days after receiving the submission on March 10, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K210714 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2021
Decision Date April 06, 2022
Days to Decision 392 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LZG — Pump, Infusion, Insulin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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