The following data is part of a premarket notification filed by Medtronic Corevalve, Llc. with the FDA for Medtronic Confida Brecker Guidewire.
| Device ID | K150465 |
| 510k Number | K150465 |
| Device Name: | Medtronic Confida Brecker Guidewire |
| Classification | Wire, Guide, Catheter |
| Applicant | Medtronic CoreValve, LLC. 3576 Unocal Place Santa Rosa, CA 95403 |
| Contact | Genevieve Balutowski Dunbar |
| Correspondent | Matthew Lobeck Medtronic CoreValve, LLC. 3576 Unocal Place Santa Rosa, CA 95403 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-23 |
| Decision Date | 2015-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169583737 | K150465 | 000 |