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FDA 510(k)

VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS

K-Number: K170362 · 2017-11-15

ApplicantColoplast Corp.
Decision Date2017-11-15
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS is a medical device manufactured by Coloplast Corp.. It received FDA 510(k) clearance on 2017-11-15 under approval number K170362. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS?

VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS is a medical device that received FDA 510(k) clearance on 2017-11-15. It is manufactured by Coloplast Corp.. The 510(k) number is K170362.

When was VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS approved by the FDA?

VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS received FDA 510(k) clearance on 2017-11-15, under approval number K170362.

What company makes VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS?

VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS is manufactured by Coloplast Corp..

What is the FDA product code for VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS?

The FDA product code for VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS is FAD.

Related Clinical Trials

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Other Devices by Coloplast Corp.

K161672SpeediCath Flex Coude K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters K170422BIOSOFT DUO DOUBLE LOOP URETERAL STENTS K170531Ureteral Dilators and Percutaneous Nephrostomy Dilators K182831SabreLine and SabreGuard Laser Fibers K180469ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent

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Related Devices (Code: FAD)

K163068pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentQ Urological Corporation K161277ConvertX Nephroureteral Stent SystemBrightwater Medical K160891Ultrathane Endoureterotomy Stent SetCook Incorporated K151051Universa Soft Ureteral Stents and Stent SetsCook Incorporated K170422BIOSOFT DUO DOUBLE LOOP URETERAL STENTSColoplast Corp. K172289pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentQ Urological Corporation

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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