FDA 510(k)

Edwards Balloon Catheter

Número K: K153069 · 2016-01-07

Data da decisão2016-01-07

Código do produtoOMZ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Edwards Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2016-01-07 under 510(k) number K153069. The device is classified under product code OMZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Edwards Balloon Catheter?

Edwards Balloon Catheter is a medical device that received FDA 510(k) clearance on 2016-01-07. The listed applicant is Edwards Lifesciences. The 510(k) number is K153069.

When did Edwards Balloon Catheter receive FDA 510(k) clearance?

Edwards Balloon Catheter received FDA 510(k) clearance on 2016-01-07, under 510(k) number K153069.

Who is the listed applicant for Edwards Balloon Catheter?

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

What is the FDA product code for Edwards Balloon Catheter?

The FDA product code for Edwards Balloon Catheter is OMZ.

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Outros registros que listam Edwards Lifesciences como candidato(a)

K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)K260105Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts K254279Edwards eSheath+ introducer set K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)K253034HemoSphere Stream Module K252364Edwards eSheath Optima introducer set

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