FDA 510(k)

NuCath Wedge Pressure Catheter

Número K: K213666 · 2022-10-06

Data da decisão2022-10-06

Código do produtoDQO

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

NuCath Wedge Pressure Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Pfm Medical, Inc.. It received FDA 510(k) clearance on 2022-10-06 under 510(k) number K213666. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NuCath Wedge Pressure Catheter?

NuCath Wedge Pressure Catheter is a medical device that received FDA 510(k) clearance on 2022-10-06. The listed applicant is Pfm Medical, Inc.. The 510(k) number is K213666.

When did NuCath Wedge Pressure Catheter receive FDA 510(k) clearance?

NuCath Wedge Pressure Catheter received FDA 510(k) clearance on 2022-10-06, under 510(k) number K213666.

Who is the listed applicant for NuCath Wedge Pressure Catheter?

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

What is the FDA product code for NuCath Wedge Pressure Catheter?

The FDA product code for NuCath Wedge Pressure Catheter is DQO.

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 Pfm Medical, Inc. como candidato(a)

K242763JetCan® Pro Safety Huber Needle K241278Sistema de Drenagem Peritoneal ASEPT® Glide K221779Sistema de Drenagem Peritoneal ASEPT K201137Asept Surgical Face Mask K192802primeMidline Catheters K173114primeMidline Catheters

Ver todos os 7 dispositivos →

Dispositivos Relacionados (Código: DQO)

K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular K250751DualView CatheterTerumo Corporation K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC K242420pNOVUS 21 MicrocatheterPhenox, Ltd.

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.