510(k) K241622

Extended Reservoir; MiniMed Reservoir by Medtronic Minimed — Product Code LZG

K241622 is an FDA 510(k) premarket notification submitted by Medtronic Minimed for the device "Extended Reservoir; MiniMed Reservoir". The FDA issued a decision of Substantially Equivalent on July 2, 2024. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Medtronic Minimed has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2024
Date Received
June 5, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Insulin
Device Class
Class II
Regulation Number
880.5725
Review Panel
CH
Submission Type