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Medtronic Minimed Sof-Site Infusion Set, Models Mmt-359S6, Mmt-359M6, Mmt-359L6, Mmt-359S9, Mmt-359M9, and Mmt-359L9

by Avail Medical Products, Inc.

510(k) K030149

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK030149 Date20 Mar 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0910-04 FDA Unclassified (pre-2012) initiated 2 Mar 2004

    Possibility of interrupted insulin flow. This posting is for a recall that occurred in March 2004, also posted on the FDA website in 2004.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FPA
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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