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FDA 510(k)

VenaCure EVLT NeverTouch Direct Introducer Sheath

K-Number: K170695 · 2017-05-30

ApplicantAngioDynamics, Inc.
Decision Date2017-05-30
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VenaCure EVLT NeverTouch Direct Introducer Sheath is a medical device manufactured by AngioDynamics, Inc.. It received FDA 510(k) clearance on 2017-05-30 under approval number K170695. 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 VenaCure EVLT NeverTouch Direct Introducer Sheath?

VenaCure EVLT NeverTouch Direct Introducer Sheath is a medical device that received FDA 510(k) clearance on 2017-05-30. It is manufactured by AngioDynamics, Inc.. The 510(k) number is K170695.

When was VenaCure EVLT NeverTouch Direct Introducer Sheath approved by the FDA?

VenaCure EVLT NeverTouch Direct Introducer Sheath received FDA 510(k) clearance on 2017-05-30, under approval number K170695.

What company makes VenaCure EVLT NeverTouch Direct Introducer Sheath?

VenaCure EVLT NeverTouch Direct Introducer Sheath is manufactured by AngioDynamics, Inc..

What is the FDA product code for VenaCure EVLT NeverTouch Direct Introducer Sheath?

The FDA product code for VenaCure EVLT NeverTouch Direct Introducer Sheath is DYB.

Other Devices by AngioDynamics, Inc.

K162914VenaCure EVLT NeverTouch Procedure Kit K171921VenaCure EVLT NeverTouch Procedure Kit K170775Mini Stick ENVI Non-Vascular Introducer Kit K163356Pulse* Spray Infusion System, Uni*Fuse Infusion System K162449Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm) K161596Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters

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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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