The following data is part of a premarket notification filed by Medtronic with the FDA for Medtronic Confida Brecker Curve Guidewire.
| Device ID | K132623 |
| 510k Number | K132623 |
| Device Name: | MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | Medtronic 3576 UNOCAL PL Santa Rosa, CA 95403 |
| Contact | Monica Hernandez-soto |
| Correspondent | Monica Hernandez-soto Medtronic 3576 UNOCAL PL 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 | 2013-08-22 |
| Decision Date | 2013-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169357055 | K132623 | 000 |