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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 the device name listed in this FDA 510(k) record. The listed applicant is Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2019-09-18 under 510(k) 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. The listed applicant is Dornier Medtech America, Inc.. The 510(k) number is K191187.

When did Dornier MINNOW Ureteral Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Dornier MINNOW Ureteral Catheter?

The FDA 510(k) record lists Dornier Medtech America, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: EYB)

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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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