510(k) K173515

Admiral Xtreme by Medtronic Vascular — Product Code LIT

K173515 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "Admiral Xtreme". The FDA issued a decision of Substantially Equivalent on April 12, 2018. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Medtronic Vascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2018
Date Received
November 14, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type