FDA 510(k)

Disposable Double Lumen Endobronchial Tube

Numéro K : K232529 · 2024-05-13

DemandeurShenzhen Insighters Medical Technology Co., Ltd.

Date de décision2024-05-13

Code produitCBI

Comité consultatifAN

DécisionSubstantially Equivalent

Résumé du dispositif

Disposable Double Lumen Endobronchial Tube is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Insighters Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-05-13 under 510(k) number K232529. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Disposable Double Lumen Endobronchial Tube?

Disposable Double Lumen Endobronchial Tube is a medical device that received FDA 510(k) clearance on 2024-05-13. The listed applicant is Shenzhen Insighters Medical Technology Co., Ltd.. The 510(k) number is K232529.

When did Disposable Double Lumen Endobronchial Tube receive FDA 510(k) clearance?

Disposable Double Lumen Endobronchial Tube received FDA 510(k) clearance on 2024-05-13, under 510(k) number K232529.

Who is the listed applicant for Disposable Double Lumen Endobronchial Tube?

The FDA 510(k) record lists Shenzhen Insighters Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Double Lumen Endobronchial Tube?

The FDA product code for Disposable Double Lumen Endobronchial Tube is CBI.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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

Autres dossiers indiquant Shenzhen Insighters Medical Technology Co., Ltd. en tant que demandeur

K242793Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters™ Insight Workstation iS-PF1.K232580Disposable Endobronchial Blocker Tube

Dispositifs connexes (Code : CBI)

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.