K052431 is an FDA 510(k) clearance for the MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1. This device is classified as a Tubing, Fluid Delivery (Class II - Special Controls, product code FPK).
Submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on November 29, 2005, 84 days after receiving the submission on September 6, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K052431 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 2005 |
| Decision Date | November 29, 2005 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPK — Tubing, Fluid Delivery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |