Submission Details
| 510(k) Number | K041830 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 07, 2004 |
| Decision Date | September 29, 2004 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
MAGELLAN RATIO DISPENSER KIT
Sep 2004
Decision
84d
Days
Class 2
Risk
About This 510(k) Submission
K041830 is an FDA 510(k) clearance for the MAGELLAN RATIO DISPENSER KIT, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on September 29, 2004, 84 days after receiving the submission on July 7, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.
Device Classification
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5860 |
Manufacturer
Similar Devices — FMF Syringe, Piston
All 747
K253068 · CMT Health PTE., Ltd.
· Feb 2026
K253769 · Instylla, Inc.
· Dec 2025
K252518 · Duopross Meditech Corporate
· Dec 2025
K251089 · Exelint International, Co.
· Dec 2025
K250192 · Promisemed Hangzhou Meditech Co., Ltd.
· Dec 2025
K250853 · Merit Medical Systems, Inc.
· Nov 2025
More from Medtronic Perfusion Systems
View all
K240666
· DTZ · Jul 2024
K181954
· CAC · Aug 2018
K123351
· DTM · Mar 2013
K101186
· DTP · Sep 2010
K090869
· DWF · Aug 2009