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FDA 510(k)

Mini Stick ENVI Non-Vascular Introducer Kit

K-Number: K170775 · 2017-07-19

ApplicantAngioDynamics, Inc.
Decision Date2017-07-19
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Mini Stick ENVI Non-Vascular Introducer Kit is a medical device manufactured by AngioDynamics, Inc.. It received FDA 510(k) clearance on 2017-07-19 under approval number K170775. 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 Mini Stick ENVI Non-Vascular Introducer Kit?

Mini Stick ENVI Non-Vascular Introducer Kit is a medical device that received FDA 510(k) clearance on 2017-07-19. It is manufactured by AngioDynamics, Inc.. The 510(k) number is K170775.

When was Mini Stick ENVI Non-Vascular Introducer Kit approved by the FDA?

Mini Stick ENVI Non-Vascular Introducer Kit received FDA 510(k) clearance on 2017-07-19, under approval number K170775.

What company makes Mini Stick ENVI Non-Vascular Introducer Kit?

Mini Stick ENVI Non-Vascular Introducer Kit is manufactured by AngioDynamics, Inc..

What is the FDA product code for Mini Stick ENVI Non-Vascular Introducer Kit?

The FDA product code for Mini Stick ENVI Non-Vascular Introducer Kit is DYB.

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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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