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 |