The following data is part of a premarket notification filed by Medtronic Core Valve, Llc. with the FDA for Medtronic Confida Brecker Guidewire.
| Device ID | K181001 |
| 510k Number | K181001 |
| Device Name: | Medtronic Confida Brecker Guidewire |
| Classification | Wire, Guide, Catheter |
| Applicant | Medtronic Core Valve, LLC. Parkmore West Galway, IE |
| Contact | Gerardine Drummond |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-04-16 |
| Decision Date | 2018-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20763000060880 | K181001 | 000 |
| 20763000758640 | K181001 | 000 |