FDA 510(k)

Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter

Número K: K230928 · 2023-08-25

Data da decisão2023-08-25

Código do produtoOWQ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vein360 Reprocessed Visions PV.018 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 2023-08-25 under 510(k) number K230928. The device is classified under product code OWQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter?

Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter is a medical device that received FDA 510(k) clearance on 2023-08-25. The listed applicant is Vein 360, LLC. The 510(k) number is K230928.

When did Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter receive FDA 510(k) clearance?

Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter received FDA 510(k) clearance on 2023-08-25, under 510(k) number K230928.

Who is the listed applicant for Vein360 Reprocessed Visions PV.018 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.018 Digital IVUS Catheter?

The FDA product code for Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter is OWQ.

Ensaios clínicos relacionados

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Vein 360, LLC como candidato(a)

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 Catheter K230584Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter K191073Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter

Dispositivos Relacionados (Código: OWQ)

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.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.