FDA 510(k)

Phasix ST Mesh

Número K: K173143 · 2018-04-25

Data da decisão2018-04-25

Código do produtoOWT

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Phasix ST Mesh is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2018-04-25 under 510(k) number K173143. The device is classified under product code OWT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Phasix ST Mesh?

Phasix ST Mesh is a medical device that received FDA 510(k) clearance on 2018-04-25. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K173143.

When did Phasix ST Mesh receive FDA 510(k) clearance?

Phasix ST Mesh received FDA 510(k) clearance on 2018-04-25, under 510(k) number K173143.

Who is the listed applicant for Phasix ST Mesh?

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

What is the FDA product code for Phasix ST Mesh?

The FDA product code for Phasix ST Mesh is OWT.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Outros registros que listam C.R. Bard, Inc. como candidato(a)

K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)K251864Rubber Utility Catheter K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,

Ver todos os 67 dispositivos →

Dispositivos Relacionados (Código: OWT)

K243241Phasix ST Umbilical Hernia PatchDavol, Inc., A Subsidiary of C.R. Bard, Inc.K233661Transorb™ Self-Gripping Resorbable MeshSofradim Production K191749TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific AB K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.K190185Phasix ST Mesh with Open Positioning SystemC.R. Bard, Inc.K163005TIGR Matrix Surgical MeshNovus Scientific AB

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.