Submission Details
| 510(k) Number | K173515 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 14, 2017 |
| Decision Date | April 12, 2018 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Admiral Xtreme
Apr 2018
Decision
149d
Days
Class 2
Risk
About This 510(k) Submission
K173515 is an FDA 510(k) clearance for the Admiral Xtreme, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Medtronic Vascular (Santa Rosa, US). The FDA issued a Cleared decision on April 12, 2018, 149 days after receiving the submission on November 14, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | LIT — Catheter, Angioplasty, Peripheral, Transluminal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
Manufacturer
Similar Devices — LIT Catheter, Angioplasty, Peripheral, Transluminal
All 401
K252512 · Abbott Medical
· Feb 2026
K251915 · Natec Medical , Ltd.
· Dec 2025
K250706 · Biotronik, Inc.
· Apr 2025
K243704 · Brosmed Medical Co., Ltd.
· Feb 2025
K241040 · Natec Medical , Ltd.
· Dec 2024
K242419 · Creagh Medical Ltd. Dba Surmodics, Inc.
· Nov 2024
More from Medtronic Vascular
View all
K232570
· DQX · Oct 2023
K232190
· DQY · Aug 2023
K230156
· DQY · Jun 2023
K220773
· MAV · Apr 2022
K192296
· DQY · Sep 2019