510(k) K041830

MAGELLAN RATIO DISPENSER KIT by Medtronic Perfusion Systems — Product Code FMF

K041830 is an FDA 510(k) premarket notification submitted by Medtronic Perfusion Systems for the device "MAGELLAN RATIO DISPENSER KIT". The FDA issued a decision of Substantially Equivalent on September 29, 2004. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Medtronic Perfusion Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2004
Date Received
July 7, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type