Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Admiral Xtreme

K-Number: K173515 · 2018-04-12

ApplicantMedtronic Vascular
Decision Date2018-04-12
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Admiral Xtreme is a medical device manufactured by Medtronic Vascular. It received FDA 510(k) clearance on 2018-04-12 under approval number K173515. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Admiral Xtreme?

Admiral Xtreme is a medical device that received FDA 510(k) clearance on 2018-04-12. It is manufactured by Medtronic Vascular. The 510(k) number is K173515.

When was Admiral Xtreme approved by the FDA?

Admiral Xtreme received FDA 510(k) clearance on 2018-04-12, under approval number K173515.

What company makes Admiral Xtreme?

Admiral Xtreme is manufactured by Medtronic Vascular.

What is the FDA product code for Admiral Xtreme?

The FDA product code for Admiral Xtreme is LIT.

Other Devices by Medtronic Vascular

K162097InTRAkit K162027TRAcelet Compression Device K161287DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak K192296Medtronic 6F Taiga Guiding Catheter K220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P) K232570Steerant™ Super Stiff Guidewire

View all 17 devices →

Related Devices (Code: LIT)

K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K162316Pirouette 014Arravasc, Ltd. K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018Boston Scientific Corporation K161427Pirouette 035Arravasc Limited K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K160004Crosstella OTWKANEKA Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑