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FDA 510(k)

Sentrant Introducer Sheath with Hydrophilic Coating

K-Number: K171866 · 2017-12-20

ApplicantMedtronic Vascular, Inc.
Decision Date2017-12-20
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sentrant Introducer Sheath with Hydrophilic Coating is a medical device manufactured by Medtronic Vascular, Inc.. It received FDA 510(k) clearance on 2017-12-20 under approval number K171866. 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 Sentrant Introducer Sheath with Hydrophilic Coating?

Sentrant Introducer Sheath with Hydrophilic Coating is a medical device that received FDA 510(k) clearance on 2017-12-20. It is manufactured by Medtronic Vascular, Inc.. The 510(k) number is K171866.

When was Sentrant Introducer Sheath with Hydrophilic Coating approved by the FDA?

Sentrant Introducer Sheath with Hydrophilic Coating received FDA 510(k) clearance on 2017-12-20, under approval number K171866.

What company makes Sentrant Introducer Sheath with Hydrophilic Coating?

Sentrant Introducer Sheath with Hydrophilic Coating is manufactured by Medtronic Vascular, Inc..

What is the FDA product code for Sentrant Introducer Sheath with Hydrophilic Coating?

The FDA product code for Sentrant Introducer Sheath with Hydrophilic Coating 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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