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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 the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2017-05-30 under 510(k) 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. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K170695.

When did VenaCure EVLT NeverTouch Direct Introducer Sheath receive FDA 510(k) clearance?

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

Who is the listed applicant for VenaCure EVLT NeverTouch Direct Introducer Sheath?

The FDA 510(k) record lists AngioDynamics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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Other records listing AngioDynamics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253198NanoKnife Generator (H78720300351US0)K252509AlphaVac Multipurpose Mechanical Aspiration System F1885K253106AngioVac CannulaK242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)K240397AlphaVac MMA F1885 System (H787253020)K231945VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits

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Related Devices (Code: DYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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