FDA 510(k)

C-PTFETM Surgical Suture

Номер K: K173922 · 2018-03-26

Дата решения2018-03-26

Код продуктаNBY

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

C-PTFETM Surgical Suture is the device name listed in this FDA 510(k) record. The listed applicant is Cp Medical, Inc.. It received FDA 510(k) clearance on 2018-03-26 under 510(k) number K173922. The device is classified under product code NBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the C-PTFETM Surgical Suture?

C-PTFETM Surgical Suture is a medical device that received FDA 510(k) clearance on 2018-03-26. The listed applicant is Cp Medical, Inc.. The 510(k) number is K173922.

When did C-PTFETM Surgical Suture receive FDA 510(k) clearance?

C-PTFETM Surgical Suture received FDA 510(k) clearance on 2018-03-26, under 510(k) number K173922.

Who is the listed applicant for C-PTFETM Surgical Suture?

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

What is the FDA product code for C-PTFETM Surgical Suture?

The FDA product code for C-PTFETM Surgical Suture is NBY.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: NBY)

K231277TissueStatDurastat, LLC K192088GOLNIT Non-aborbable PTFE Surgical SutureAntarma, LLC Dba Golnit Sutures K180992BiotexPurgo Biologics, Inc.K191317StitchKitOrigami Surgical K181578DemeTECH PTFE Nonabsorbable Surgical SutureDemetech Corporation K180630PTFE SURGICAL SUTUREOmnia Spa

Официальный источник

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