FDA 510(k)

C3 Wave System

Número K: K170934 · 2017-12-06

RequerenteMedical Components, Inc (Dba Medcomp_

Data da decisão2017-12-06

Código do produtoLJS

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

C3 Wave System is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc (Dba Medcomp_. It received FDA 510(k) clearance on 2017-12-06 under 510(k) number K170934. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the C3 Wave System?

C3 Wave System is a medical device that received FDA 510(k) clearance on 2017-12-06. The listed applicant is Medical Components, Inc (Dba Medcomp_. The 510(k) number is K170934.

When did C3 Wave System receive FDA 510(k) clearance?

C3 Wave System received FDA 510(k) clearance on 2017-12-06, under 510(k) number K170934.

Who is the listed applicant for C3 Wave System?

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

What is the FDA product code for C3 Wave System?

The FDA product code for C3 Wave System is LJS.

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 Medical Components, Inc (Dba Medcomp_ como candidato(a)

K232945Trio-CT® Triple Lumen Catheter w/ Curved Extensions K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes K192807Duo-Flow Side x Side Double Lumen Catheter K183219Trio-CT Triple Lumen Catheter K18117512F Tri-Flow Triple Lumen Catheter K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes

Ver todos os 9 dispositivos →

Dispositivos Relacionados (Código: LJS)

K260929Neonav ECG Tip Location SystemNavi Medical Technologies K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve TechnologySpectrum Vascular K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrAccess Vascular, Inc.K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)Access Vascular, Inc.K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc.

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.