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

FDA 510(k)

White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter

K-Number: K162448 · 2017-05-26

ApplicantCook Incorporated
Decision Date2017-05-26
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-05-26 under approval number K162448. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter?

White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter is a medical device that received FDA 510(k) clearance on 2017-05-26. It is manufactured by Cook Incorporated. The 510(k) number is K162448.

When was White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter approved by the FDA?

White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter received FDA 510(k) clearance on 2017-05-26, under approval number K162448.

What company makes White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter?

White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter is manufactured by Cook Incorporated.

What is the FDA product code for White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter?

The FDA product code for White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter is DQO.

Related Clinical Trials

NCT07216170 REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke NOT_YET_RECRUITING NCT07595666 Comparison of NeuroEXPLORER PET/CT Versus Standard-of-care PET/CT of the Head and Neck Region. ENROLLING_BY_INVITATION NCT04058990 Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV) ACTIVE_NOT_RECRUITING NCT07559630 Rectal Arterial Embolization vs Band Ligation for the Treatment of Internal hemOrrhoidS RECRUITING NCT07397390 an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified Lesions ENROLLING_BY_INVITATION

Other Devices by Cook Incorporated

K160884CXI Support Catheter K161822Torcon NB Advantage Catheters K161496Turbo-Flo PICC Sets K160217uVue HSG/SHG Catheter K161002Aprima Smartesis Centesis Pump K153761Emergency Transtracheal Airway Catheter

View all 147 devices →

Related Devices (Code: DQO)

K161822Torcon NB Advantage CathetersCook Incorporated K161287DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-PakMedtronic Vascular K160662Surefire Infusion SystemSurefire Medical, Inc. K153125IntraNovo MicrocatheterTexasmedical Technologies, Inc. K170544Langston dual lumen catheterVascular Solutions, Inc. K173289Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing CatheterCook Incorporated

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.

↑