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FDA 510(k)

OPTION VENA CAVA FILTER

K-Number: K081410 · 2009-06-04

ApplicantRex Medical
Decision Date2009-06-04
Product CodeDTK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OPTION VENA CAVA FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Rex Medical. It received FDA 510(k) clearance on 2009-06-04 under 510(k) number K081410. 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 OPTION VENA CAVA FILTER?

OPTION VENA CAVA FILTER is a medical device that received FDA 510(k) clearance on 2009-06-04. The listed applicant is Rex Medical. The 510(k) number is K081410.

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

OPTION VENA CAVA FILTER received FDA 510(k) clearance on 2009-06-04, under 510(k) number K081410.

Who is the listed applicant for OPTION VENA CAVA FILTER?

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

What is the FDA product code for OPTION VENA CAVA FILTER?

The FDA product code for OPTION VENA CAVA FILTER is DTK.

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Other records listing Rex Medical 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.

K120346CLEANER ROTATIONAL THROMBECTOMY SYSTEMK113103SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICEK102043ULTRASTREAM CHRONIC HEMODIALYSIS CATHETERK091029CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)K07142215.5F HEMO-STREAM HEMODIALYSIS CATHETER SETK051468INNER-LOCK INTRODUCER SHEATH

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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

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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