FDA 510(k)

RocaTub Ureteral Catheter

Номер K: K192183 · 2020-04-23

ЗаявительPromepal Sam

Дата решения2020-04-23

Код продуктаEYB

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

RocaTub Ureteral Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Promepal Sam. It received FDA 510(k) clearance on 2020-04-23 under 510(k) number K192183. The device is classified under product code EYB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the RocaTub Ureteral Catheter?

RocaTub Ureteral Catheter is a medical device that received FDA 510(k) clearance on 2020-04-23. The listed applicant is Promepal Sam. The 510(k) number is K192183.

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

RocaTub Ureteral Catheter received FDA 510(k) clearance on 2020-04-23, under 510(k) number K192183.

Who is the listed applicant for RocaTub Ureteral Catheter?

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

What is the FDA product code for RocaTub Ureteral Catheter?

The FDA product code for RocaTub Ureteral Catheter is EYB.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: EYB)

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

Официальный источник

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