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FDA 510(k)

Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter

N.º K: K230584 · 2023-06-06

SolicitanteVein 360, LLC
Fecha de decisión2023-06-06
Código de productoOWQ
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Vein 360, LLC. It received FDA 510(k) clearance on 2023-06-06 under 510(k) number K230584. The device is classified under product code OWQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter?

Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter is a medical device that received FDA 510(k) clearance on 2023-06-06. The listed applicant is Vein 360, LLC. The 510(k) number is K230584.

When did Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter receive FDA 510(k) clearance?

Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter received FDA 510(k) clearance on 2023-06-06, under 510(k) number K230584.

Who is the listed applicant for Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter?

The FDA 510(k) record lists Vein 360, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter?

The FDA product code for Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter is OWQ.

Ensayos clínicos relacionados

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Otros registros que enlistan a Vein 360, LLC 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.

K232584Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS CatheterK230928Vein360 Reprocessed Visions PV.018 Digital IVUS CatheterK191073Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter

Dispositivos relacionados (Código: OWQ)

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.

K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)Sterilmed, Inc.K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)Surgical Instrument Service and Savings, Inc.K250592NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)Northeast Scientific, Inc.K243101Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)Surgical Instrument Service and Savings, Inc.K234064Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)Surgical Instrument Service and Savings, Inc.K232130Medline ReNewal Reprocessed ViewFlex Xtra ICE CatheterSurgical Instrument Services and Savings, Inc.

Fuente oficial

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