FDA 510(k)

ViewFlex Xtra ICE Catheter

N.º K: K223077 · 2022-12-07

SolicitanteIrvine Biomedical, A St. Jude Medical Company

Fecha de decisión2022-12-07

Código de productoOBJ

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

ViewFlex Xtra ICE Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Irvine Biomedical, A St. Jude Medical Company. It received FDA 510(k) clearance on 2022-12-07 under 510(k) number K223077. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ViewFlex Xtra ICE Catheter?

ViewFlex Xtra ICE Catheter is a medical device that received FDA 510(k) clearance on 2022-12-07. The listed applicant is Irvine Biomedical, A St. Jude Medical Company. The 510(k) number is K223077.

When did ViewFlex Xtra ICE Catheter receive FDA 510(k) clearance?

ViewFlex Xtra ICE Catheter received FDA 510(k) clearance on 2022-12-07, under 510(k) number K223077.

Who is the listed applicant for ViewFlex Xtra ICE Catheter?

The FDA 510(k) record lists Irvine Biomedical, A St. Jude Medical Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ViewFlex Xtra ICE Catheter?

The FDA product code for ViewFlex Xtra ICE Catheter is OBJ.

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Dispositivos relacionados (Código: OBJ)

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Fuente oficial

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