FDA 510(k)

Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)

Numéro K : K223612 · 2023-02-21

Date de décision2023-02-21

Code produitKNW

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) is the device name listed in this FDA 510(k) record. The listed applicant is Ranfac Corporation. It received FDA 510(k) clearance on 2023-02-21 under 510(k) number K223612. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)?

Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) is a medical device that received FDA 510(k) clearance on 2023-02-21. The listed applicant is Ranfac Corporation. The 510(k) number is K223612.

When did Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) receive FDA 510(k) clearance?

Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) received FDA 510(k) clearance on 2023-02-21, under 510(k) number K223612.

Who is the listed applicant for Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)?

The FDA 510(k) record lists Ranfac Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)?

The FDA product code for Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) is KNW.

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 Ranfac Corporation en tant que demandeur

K202287Ran-Flex-B Bone Marrow Aspiration Needle K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,K183146Ranfac Cartilage Biopsy Needle

Dispositifs connexes (Code : KNW)

K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLC K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery CharDevicor Medical Products, 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.