Dornier MINNOW Ureteral Catheter— 510(k) K191187

Name: FDA 510(k) clearance K191187
Creator: U.S. Food and Drug Administration
Published: 2019-09-18

Substantially Equivalent

Dornier Medtech America, Inc.

FDA 510(k) clearance K191187 for Dornier MINNOW Ureteral Catheter, Substantially Equivalent on 2019-09-18. Applicant: Dornier Medtech America, Inc.. Device class: 2.

Clearance details

Applicant: Dornier Medtech America, Inc.
Product code: Code EYB
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2019-05-03
Decision date: 2019-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kennesaw, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EYB

view all

K192183 — RocaTub Ureteral Catheter2020-04-23
K183323 — UPJ Occlusion Balloon Catheter2019-08-05
K182695 — Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter2019-06-17
K182122 — Ureteric Catheters2018-10-04
K180182 — Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter2018-09-14

More clearances from Dornier Medtech America, Inc.

view all

K221903 — Delta III Pro2023-02-22
K213252 — Dornier Thulio2022-07-27
K220871 — Nautilus2022-04-18
K210394 — Electrosurgical accessory2021-05-19
K201815 — Dornier MAGELLAN Ureteral Access Sheath2020-11-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.