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FDA 510(k)

CRUX VENA CAVA FILTER SYSTEM

K-Number: K122585 · 2013-01-17

ApplicantCrux Biomedical
Decision Date2013-01-17
Product CodeDTK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CRUX VENA CAVA FILTER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Crux Biomedical. It received FDA 510(k) clearance on 2013-01-17 under 510(k) number K122585. 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 CRUX VENA CAVA FILTER SYSTEM?

CRUX VENA CAVA FILTER SYSTEM is a medical device that received FDA 510(k) clearance on 2013-01-17. The listed applicant is Crux Biomedical. The 510(k) number is K122585.

When did CRUX VENA CAVA FILTER SYSTEM receive FDA 510(k) clearance?

CRUX VENA CAVA FILTER SYSTEM received FDA 510(k) clearance on 2013-01-17, under 510(k) number K122585.

Who is the listed applicant for CRUX VENA CAVA FILTER SYSTEM?

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

What is the FDA product code for CRUX VENA CAVA FILTER SYSTEM?

The FDA product code for CRUX VENA CAVA FILTER SYSTEM is DTK.

Related Clinical Trials

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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Other records listing Crux Biomedical 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.

K120402CRUX VENA CAVA FILTER SYSTEM

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 ApsK211874Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe Aps

Official Source

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