Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OPTION ELITE VENA CAVA FILTER SYSTEM

K-Number: K133243 · 2013-12-17

ApplicantRex Medical, L.P.
Decision Date2013-12-17
Product CodeDTK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OPTION ELITE VENA CAVA FILTER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Rex Medical, L.P.. It received FDA 510(k) clearance on 2013-12-17 under 510(k) number K133243. 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 ELITE VENA CAVA FILTER SYSTEM?

OPTION ELITE VENA CAVA FILTER SYSTEM is a medical device that received FDA 510(k) clearance on 2013-12-17. The listed applicant is Rex Medical, L.P.. The 510(k) number is K133243.

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

OPTION ELITE VENA CAVA FILTER SYSTEM received FDA 510(k) clearance on 2013-12-17, under 510(k) number K133243.

Who is the listed applicant for OPTION ELITE VENA CAVA FILTER SYSTEM?

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

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

The FDA product code for OPTION ELITE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Rex Medical, L.P. 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.

K212351Revolution Peripheral Atherectomy SystemK191419Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy GuidewireK173389Rex Medical Aspiration PumpK060904CLEANER ROTATIONAL THROMBECTOMY SYSTEMK042399MODIFICATION TO SHORT INTRODUCER SHEATH

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.

↑