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FDA 510(k)

Dornier MINNOW Ureteral Catheter

K-Number: K191187 · 2019-09-18

ApplicantDornier Medtech America, Inc.
Decision Date2019-09-18
Product CodeEYB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Dornier MINNOW Ureteral Catheter is a medical device manufactured by Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2019-09-18 under approval number K191187. 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 Dornier MINNOW Ureteral Catheter?

Dornier MINNOW Ureteral Catheter is a medical device that received FDA 510(k) clearance on 2019-09-18. It is manufactured by Dornier Medtech America, Inc.. The 510(k) number is K191187.

When was Dornier MINNOW Ureteral Catheter approved by the FDA?

Dornier MINNOW Ureteral Catheter received FDA 510(k) clearance on 2019-09-18, under approval number K191187.

What company makes Dornier MINNOW Ureteral Catheter?

Dornier MINNOW Ureteral Catheter is manufactured by Dornier Medtech America, Inc..

What is the FDA product code for Dornier MINNOW Ureteral Catheter?

The FDA product code for Dornier MINNOW Ureteral Catheter is EYB.

Related Clinical Trials

NCT06615713 CLinical Evaluation of Aspiration for Removal ANd ClearancE of Stones COMPLETED NCT06798753 Occlusion Balloon vs. 5FR Ureteral Catheter COMPLETED

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Related Devices (Code: EYB)

K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric CathetersColoplast Corp. K182122Ureteric CathetersColoplast Corp. K180182Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access CatheterCook Incorporated 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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