FDA 510(k)

Reprocessador de Probes de Echocardiografia Transesofágica ASTRA, Reprocessador de Probes Endovaginal/Endoretral ASTRA VR

Número K: K163313 · 2017-06-09

RequerenteCIVCO Medical Instruments Co., Inc.

Data da decisão2017-06-09

Código do produtoITX

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor is the device name listed in this FDA 510(k) record. The listed applicant is CIVCO Medical Instruments Co., Inc.. It received FDA 510(k) clearance on 2017-06-09 under 510(k) number K163313. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor?

ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor is a medical device that received FDA 510(k) clearance on 2017-06-09. The listed applicant is CIVCO Medical Instruments Co., Inc.. The 510(k) number is K163313.

When did ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor receive FDA 510(k) clearance?

ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor received FDA 510(k) clearance on 2017-06-09, under 510(k) number K163313.

Who is the listed applicant for ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor?

The FDA 510(k) record lists CIVCO Medical Instruments Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor?

The FDA product code for ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor is ITX.

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 CIVCO Medical Instruments Co., Inc. como candidato(a)

K260114Align® Cover and Pad Guidance Tool K231783VitroPRO K222052VitroPRO K211270CIV-Clear cover K160806Verza Guidance System

Dispositivos Relacionados (Código: ITX)

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm Corporation K254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLC K261014Accuro® 3S Needle Guide KitRivanna Medical, 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.