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FDA 510(k)

Sentry IVC filter

K-Number: K162875 · 2017-02-17

ApplicantNovate Medical , Ltd.
Decision Date2017-02-17
Product CodeDTK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sentry IVC filter is the device name listed in this FDA 510(k) record. The listed applicant is Novate Medical , Ltd.. It received FDA 510(k) clearance on 2017-02-17 under 510(k) number K162875. The device is classified under product code DTK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sentry IVC filter?

Sentry IVC filter is a medical device that received FDA 510(k) clearance on 2017-02-17. The listed applicant is Novate Medical , Ltd.. The 510(k) number is K162875.

When did Sentry IVC filter receive FDA 510(k) clearance?

Sentry IVC filter received FDA 510(k) clearance on 2017-02-17, under 510(k) number K162875.

Who is the listed applicant for Sentry IVC filter?

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

What is the FDA product code for Sentry IVC filter?

The FDA product code for Sentry IVC filter is DTK.

Other records listing Novate Medical , Ltd. 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.

K181202Sentry IVC FilterK173236Sentry IVC Filter

Related Devices (Code: DTK)

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.

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Official Source

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