The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Medtronic Minimed Countach Infusion Set, Model 313.
| Device ID | K032485 |
| 510k Number | K032485 |
| Device Name: | MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313 |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST. Northridge, CA 91325 -1219 |
| Contact | Mirielle Mengotto |
| Correspondent | Mirielle Mengotto MEDTRONIC MINIMED 18000 DEVONSHIRE ST. Northridge, CA 91325 -1219 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-12 |
| Decision Date | 2003-10-28 |
| Summary: | summary |