FDA 510(k)

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

K-Number: K180182 · 2018-09-14

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 the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-09-14 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K180182.

When did Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT02633124Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants.TERMINATED NCT06668766Single Lumen Midline Catheter vs Long Peripheral Intravenous Cather for Difficult Intravenous Access in the EDCOMPLETED NCT07585188Neonatal Catheter Lock for Infection PreventionNOT_YET_RECRUITING NCT07779317Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered NursesRECRUITING

Other records listing Cook Incorporated as applicant

PMA P020018SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT K233177Nest VT Vitrification Device K222254Gunther Tulip Vena Cava Filter Retrieval Set K223098Bakri Essential Postpartum Balloon K210734Endovascular Dilator and Sets K203670Extra Large Check-Flo Introducer

View all 147 devices →

Related Devices (Code: EYB)

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

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.