FDA 510(k)

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

K-Number: K100432 · 2010-07-09

Decision Date2010-07-09

Product CodeFPA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Minimed. It received FDA 510(k) clearance on 2010-07-09 under 510(k) number K100432. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS is a medical device that received FDA 510(k) clearance on 2010-07-09. The listed applicant is Medtronic Minimed. The 510(k) number is K100432.

When did POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS receive FDA 510(k) clearance?

POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS received FDA 510(k) clearance on 2010-07-09, under 510(k) number K100432.

Who is the listed applicant for POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS?

The FDA 510(k) record lists Medtronic Minimed as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS?

The FDA product code for POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS is FPA.

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Related Devices (Code: FPA)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.