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FDA 510(k)

TRAcelet Compression Device

K-Number: K162027 · 2016-10-21

ApplicantMedtronic Vascular
Decision Date2016-10-21
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRAcelet Compression Device is a medical device manufactured by Medtronic Vascular. It received FDA 510(k) clearance on 2016-10-21 under approval number K162027. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAcelet Compression Device?

TRAcelet Compression Device is a medical device that received FDA 510(k) clearance on 2016-10-21. It is manufactured by Medtronic Vascular. The 510(k) number is K162027.

When was TRAcelet Compression Device approved by the FDA?

TRAcelet Compression Device received FDA 510(k) clearance on 2016-10-21, under approval number K162027.

What company makes TRAcelet Compression Device?

TRAcelet Compression Device is manufactured by Medtronic Vascular.

What is the FDA product code for TRAcelet Compression Device?

The FDA product code for TRAcelet Compression Device is DXC.

Related Clinical Trials

NCT07613931 Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment NOT_YET_RECRUITING NCT07603531 Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb Lymphedema NOT_YET_RECRUITING NCT07305870 Sequential Compression Device in Distributive Peripheral Edema and Hemodynamic Stability Among Patients in Critical Care Units ENROLLING_BY_INVITATION NCT07600489 A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers NOT_YET_RECRUITING NCT07573189 The Effects of Recovery Compression Boots on Blood Lactate Levels, Functional Movement, and Joint Ange of Motion in Collegiate Athletes. ACTIVE_NOT_RECRUITING NCT06911385 Augmenting Cerebral Blood Flow in Acute Ischemic Stroke NOT_YET_RECRUITING

Other Devices by Medtronic Vascular

K162097InTRAkit K161287DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak K173515Admiral Xtreme 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

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Related Devices (Code: DXC)

K161315Vein Clamps, Artery ClampsAros Surgical Instruments Corporation K153259VasoStat Hemostasis DeviceForge Medical, Inc. K170958ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cmTricol Biomedical, Inc. K163693IntraClude Intra-Aortic Occlusion DeviceEdwards Lifesciences, LLC K162988PreludeSYNC Radial Compression DeviceMerit Medical Systems, Inc. K180723PreludeSYNC DISTAL Radial Compression SystemMerit Medical Systems, Inc.

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.

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