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FDA 510(k)

Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter

K-Number: K180182 · 2018-09-14

ApplicantCook Incorporated
Decision Date2018-09-14
Product CodeEYB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-09-14 under approval number K180182. The device is classified under product code EYB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter?

Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter is a medical device that received FDA 510(k) clearance on 2018-09-14. It is manufactured by Cook Incorporated. The 510(k) number is K180182.

When was Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter approved by the FDA?

Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter received FDA 510(k) clearance on 2018-09-14, under approval number K180182.

What company makes Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter?

Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter is manufactured by Cook Incorporated.

What is the FDA product code for Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter?

The FDA product code for Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter is EYB.

Related Clinical Trials

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Related Devices (Code: EYB)

K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric CathetersColoplast Corp. K182122Ureteric CathetersColoplast Corp. K191187Dornier MINNOW Ureteral CatheterDornier Medtech America, Inc. K183323UPJ Occlusion Balloon CatheterCook Incorporated K182695Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterCook Incorporated K192183RocaTub Ureteral CatheterPromepal Sam

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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