Fecha de decisión2016-03-24
Código de productoNCX
Comité asesorCV
DecisiónUnknown
Resumen del 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.
Preguntas frecuentes
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.
Ensayos clínicos relacionados
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Otros registros que enlistan a Zoll Circulation, Inc. como solicitante
Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.
K250979Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)K231182Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management SystemK221700AutoPulse NXT Resuscitation SystemK223746Solex 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 ConsoleK220008Solex 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 ConsoleK213031Solex 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 Console Ver todos los 7 dispositivos →
Dispositivos relacionados (Código: NCX)
Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.
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.
Fuente oficial
Ver en la base de datos de la FDA →Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.