Fecha de decisión2016-04-05
Código de productoDSA
Comité asesorCV
DecisiónSubstantially Equivalent
Resumen del dispositivo
Disposable Temporary Pacing Cable is the device name listed in this FDA 510(k) record. The listed applicant is Tiger Medical Products. It received FDA 510(k) clearance on 2016-04-05 under 510(k) number K152947. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Preguntas frecuentes
What is the Disposable Temporary Pacing Cable?
Disposable Temporary Pacing Cable is a medical device that received FDA 510(k) clearance on 2016-04-05. The listed applicant is Tiger Medical Products. The 510(k) number is K152947.
When did Disposable Temporary Pacing Cable receive FDA 510(k) clearance?
Disposable Temporary Pacing Cable received FDA 510(k) clearance on 2016-04-05, under 510(k) number K152947.
Who is the listed applicant for Disposable Temporary Pacing Cable?
The FDA 510(k) record lists Tiger Medical Products as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Disposable Temporary Pacing Cable?
The FDA product code for Disposable Temporary Pacing Cable is DSA.
Ensayos clínicos relacionados
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.
Dispositivos relacionados (Código: DSA)
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.
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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.