The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Minimed Quick-serter.
| Device ID | K160860 |
| 510k Number | K160860 |
| Device Name: | MiniMed Quick-serter |
| Classification | Introducer, Syringe Needle |
| Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE STREET Northridge, CA 91325 |
| Contact | Noreen Bajwa |
| Correspondent | Noreen Bajwa MEDTRONIC MINIMED 18000 DEVONSHIRE STREET Northridge, CA 91325 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-29 |
| Decision Date | 2016-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169698116 | K160860 | 000 |
| 00763000573690 | K160860 | 000 |
| 00643169768086 | K160860 | 000 |
| 00763000354817 | K160860 | 000 |