FDA 510(k)

SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter

Numéro K : K201377 · 2020-10-09

Date de décision2020-10-09

Code produitLIT

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corporation. It received FDA 510(k) clearance on 2020-10-09 under 510(k) number K201377. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter?

SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2020-10-09. The listed applicant is Cordis Corporation. The 510(k) number is K201377.

When did SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter receive FDA 510(k) clearance?

SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter received FDA 510(k) clearance on 2020-10-09, under 510(k) number K201377.

Who is the listed applicant for SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter?

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

What is the FDA product code for SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter?

The FDA product code for SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter is LIT.

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 Cordis Corporation en tant que demandeur

K220654ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire K212977SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands K210626SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter K202167Brite Tip Radianz Guiding Sheath K201333SABER .035 PTA Dilatation Catheter K181592RAIN Sheath Transradial

Voir tous les 8 dispositifs →

Dispositifs connexes (Code : LIT)

K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.K260304WAVE PTA Balloon CatheterWAVE Medical AG K252512Armada™ 14 NC PTA CatheterABBOTT MEDICAL K251915Cathéter Amethyst HP PTA OTW 0.035Natec Medical , Ltd.K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, 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.