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FDA 510(k)

Sentry IVC Filter

K-Number: K181202 · 2018-06-06

ApplicantNovate Medical , Ltd.
Decision Date2018-06-06
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 2018-06-06 under 510(k) number K181202. 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 2018-06-06. The listed applicant is Novate Medical , Ltd.. The 510(k) number is K181202.

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

Sentry IVC Filter received FDA 510(k) clearance on 2018-06-06, under 510(k) number K181202.

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.

K173236Sentry IVC FilterK162875Sentry 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.

K242612Option ELITE Vena Cava Filter System (352506070E 352506100E)Argon Medical Devices, Inc.K240578VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemB.Braun Medical, Inc.K241507ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)Aln S.A.R.L.K240257Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery KitBdK233680Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava FilterWilliam Cook Europe ApsK211875Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe Aps

Official Source

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