FDA 510(k)

EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter

Numéro K : K210313 · 2022-12-30

DemandeurShanghai Microport EP Medtech Co., Ltd.

Date de décision2022-12-30

Code produitDRF

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Microport EP Medtech Co., Ltd.. It received FDA 510(k) clearance on 2022-12-30 under 510(k) number K210313. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter?

EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter is a medical device that received FDA 510(k) clearance on 2022-12-30. The listed applicant is Shanghai Microport EP Medtech Co., Ltd.. The 510(k) number is K210313.

When did EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter receive FDA 510(k) clearance?

EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter received FDA 510(k) clearance on 2022-12-30, under 510(k) number K210313.

Who is the listed applicant for EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter?

The FDA 510(k) record lists Shanghai Microport EP Medtech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter?

The FDA product code for EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter is DRF.

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 Shanghai Microport EP Medtech Co., Ltd. en tant que demandeur

K212625PathBuilder Transseptal Needle K212626PathBuilder Transseptal Guiding Introducer K211530PathBuilder Steerable Introducer

Dispositifs connexes (Code : DRF)

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific Corporation K240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific Corporation K233900Nordica PV Cryo Mapping CatheterSynaptic Medical Corporation K233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.

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.