FDA 510(k)

NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter

N.º K: K223026 · 2023-02-03

Fecha de decisión2023-02-03

Código de productoOWQ

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Northeast Scientific, Inc.. It received FDA 510(k) clearance on 2023-02-03 under 510(k) number K223026. 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 NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter?

NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is a medical device that received FDA 510(k) clearance on 2023-02-03. The listed applicant is Northeast Scientific, Inc.. The 510(k) number is K223026.

When did NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter receive FDA 510(k) clearance?

NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter received FDA 510(k) clearance on 2023-02-03, under 510(k) number K223026.

Who is the listed applicant for NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter?

The FDA 510(k) record lists Northeast Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter?

The FDA product code for NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is OWQ.

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.

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

Otros registros que enlistan a Northeast Scientific, Inc. como solicitante

K250592NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)K220171NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter K200195NES Reprocessed Visions PV .014P RX Digital IVUS 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.

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.