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)

InTRAkit

K-Number: K162097 · 2016-11-17

ApplicantMedtronic Vascular
Decision Date2016-11-17
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

InTRAkit is a medical device manufactured by Medtronic Vascular. It received FDA 510(k) clearance on 2016-11-17 under approval number K162097. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InTRAkit?

InTRAkit is a medical device that received FDA 510(k) clearance on 2016-11-17. It is manufactured by Medtronic Vascular. The 510(k) number is K162097.

When was InTRAkit approved by the FDA?

InTRAkit received FDA 510(k) clearance on 2016-11-17, under approval number K162097.

What company makes InTRAkit?

InTRAkit is manufactured by Medtronic Vascular.

What is the FDA product code for InTRAkit?

The FDA product code for InTRAkit is DYB.

Other Devices by Medtronic Vascular

K162027TRAcelet Compression Device 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

View all 17 devices →

Related Devices (Code: DYB)

K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelAccess Scientific, LLC K162769Pinpoint GT Introducer NeedleC.R. Bard, Inc. K153771TXM Guiding SheathTexasmedical Technologies, Inc. K162184Edwards eSheath Introducer SetEdward Lifesciences K153494HQS Introducer (Model 2064-HQS)Alseal K152913GORE TIPS Set, GORE TIPS Sheath, GORE TIPS NeedleCreganna Medical Aslo Business AS Cregganna Tactx Medical

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.

↑