The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Admiral Xtreme.
| Device ID | K173515 |
| 510k Number | K173515 |
| Device Name: | Admiral Xtreme |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Medtronic Vascular 3576 Unoacal Place Santa Rosa, CA 95403 |
| Contact | Maddalena Pinsi |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-11-14 |
| Decision Date | 2018-04-12 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ADMIRAL XTREME 79024620 not registered Dead/Abandoned |
INVATEC S.P.A. 2006-04-06 |