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FDA 510(k)

In-Ka Ureteral Balloon Dilatation Catheter

K-Number: K201007 · 2020-06-11

ApplicantColoplast Corp.
Decision Date2020-06-11
Product CodeEZN
Advisory CommitteeGU
DecisionUnknown

Device Summary

In-Ka Ureteral Balloon Dilatation Catheter is a medical device manufactured by Coloplast Corp.. It received FDA 510(k) clearance on 2020-06-11 under approval number K201007. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the In-Ka Ureteral Balloon Dilatation Catheter?

In-Ka Ureteral Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2020-06-11. It is manufactured by Coloplast Corp.. The 510(k) number is K201007.

When was In-Ka Ureteral Balloon Dilatation Catheter approved by the FDA?

In-Ka Ureteral Balloon Dilatation Catheter received FDA 510(k) clearance on 2020-06-11, under approval number K201007.

What company makes In-Ka Ureteral Balloon Dilatation Catheter?

In-Ka Ureteral Balloon Dilatation Catheter is manufactured by Coloplast Corp..

What is the FDA product code for In-Ka Ureteral Balloon Dilatation Catheter?

The FDA product code for In-Ka Ureteral Balloon Dilatation Catheter is EZN.

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Other Devices by Coloplast Corp.

K161672SpeediCath Flex Coude K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters K170362VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS K170422BIOSOFT DUO DOUBLE LOOP URETERAL STENTS K170531Ureteral Dilators and Percutaneous Nephrostomy Dilators K182831SabreLine and SabreGuard Laser Fibers

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Related Devices (Code: EZN)

K170531Ureteral Dilators and Percutaneous Nephrostomy DilatorsColoplast Corp. K173654Ureteral Dilator Sets, Ureteral DilatorsCook Incorporated K180756Safety Wire Guide IntroducerCook Incorporated K180028Cook 810 Set, Desilets-Hoffman Introducer SetCook Incorporated K172588Balloon Catheter and Balloon Ureteral Dilator SetCook Incorporated K190612EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc.

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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