K020147 is an FDA 510(k) clearance for the MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Medtronic Perfusion Systems (Brooklyn Park, US). The FDA issued a Cleared decision on April 3, 2002, 77 days after receiving the submission on January 16, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K020147 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 2002 |
| Decision Date | April 03, 2002 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |