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FDA 510(k)

Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit

Número K: K153226 · 2016-03-24

RequerenteZoll Circulation, Inc.
Data da decisão2016-03-24
Código do produtoNCX
Comité consultivoCV
DecisãoUnknown

Resumo do dispositivo

Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit is the device name listed in this FDA 510(k) record. The listed applicant is Zoll Circulation, Inc.. It received FDA 510(k) clearance on 2016-03-24 under 510(k) number K153226. The device is classified under product code NCX. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Perguntas frequentes

What is the Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit?

Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit is a medical device that received FDA 510(k) clearance on 2016-03-24. The listed applicant is Zoll Circulation, Inc.. The 510(k) number is K153226.

When did Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit receive FDA 510(k) clearance?

Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit received FDA 510(k) clearance on 2016-03-24, under 510(k) number K153226.

Who is the listed applicant for Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit?

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

What is the FDA product code for Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit?

The FDA product code for Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit is NCX.

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Ver todos os 7 dispositivos →

Dispositivos Relacionados (Código: NCX)

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.

K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ ConsoleZoll Circulation, Inc.K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ ConsoleZoll Circulation, Inc.K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP ConsoleZoll Circulation, Inc.K152946TEMPEDYSeiratherm GmbHK153162HypocoreNovocor Medical Systems, Inc.

Fonte oficial

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