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)

OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER

K-Number: K091077 · 2010-02-04

ApplicantCordis Corp., A Johnson & Johnson Co.
Decision Date2010-02-04
Product CodeDTK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp., A Johnson & Johnson Co.. It received FDA 510(k) clearance on 2010-02-04 under 510(k) number K091077. 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 OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER?

OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER is a medical device that received FDA 510(k) clearance on 2010-02-04. The listed applicant is Cordis Corp., A Johnson & Johnson Co.. The 510(k) number is K091077.

When did OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER receive FDA 510(k) clearance?

OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER received FDA 510(k) clearance on 2010-02-04, under 510(k) number K091077.

Who is the listed applicant for OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER?

The FDA 510(k) record lists Cordis Corp., A Johnson & Johnson Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER?

The FDA product code for OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER 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 Cordis Corp., A Johnson & Johnson Co. 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.

K131225ADROIT GUIDING CATHETERK083814OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120K062531ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE

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.

↑