FDA 510(k)

Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes

Numéro K : K202176 · 2020-09-03

DemandeurMedical Components, Inc. (dba MedComp)

Date de décision2020-09-03

Code produitMSD

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc. (dba MedComp). It received FDA 510(k) clearance on 2020-09-03 under 510(k) number K202176. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes?

Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes is a medical device that received FDA 510(k) clearance on 2020-09-03. The listed applicant is Medical Components, Inc. (dba MedComp). The 510(k) number is K202176.

When did Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes receive FDA 510(k) clearance?

Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes received FDA 510(k) clearance on 2020-09-03, under 510(k) number K202176.

Who is the listed applicant for Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes?

The FDA 510(k) record lists Medical Components, Inc. (dba MedComp) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes?

The FDA product code for Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes is MSD.

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 Medical Components, Inc. (dba MedComp) en tant que demandeur

K232945Trio-CT® Triple Lumen Catheter w/ Curved Extensions K192807Duo-Flow Side x Side Double Lumen Catheter K183219Trio-CT Triple Lumen Catheter K18117512F Tri-Flow Triple Lumen Catheter K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes K180567C3 Wave System

Voir tous les 9 dispositifs →

Dispositifs connexes (Code : MSD)

K241581Hemodialysis CatheterHaolang Medical USA Corporation K210461End CapMedical Components Inc (Medcomp)K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc.K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc.K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc.K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, 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.