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FDA 510(k)

SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter

K-Number: K201377 · 2020-10-09

ApplicantCordis Corporation
Decision Date2020-10-09
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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NCT07397390an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified LesionsENROLLING_BY_INVITATIONNCT05731700CVT-ISR First in Human Trial for Coronary In-Stent RestenosisCOMPLETEDNCT05734157CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal ArteryCOMPLETEDNCT06330493AcoArt Litos PCB Below-the-knee Global TrialTERMINATEDNCT03466151RESOLUTE ONYX China RCT StudyACTIVE_NOT_RECRUITINGNCT03471845RESOLUTE ONYX China Single Arm StudyACTIVE_NOT_RECRUITING

Other records listing Cordis Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220654ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireK212977SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbandsK210626SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation CatheterK202167Brite Tip Radianz Guiding SheathK201333SABER .035 PTA Dilatation CatheterK181592RAIN Sheath Transradial

View all 8 devices →

Related Devices (Code: LIT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260304WAVE PTA Balloon CatheterWAVE Medical AGK252512Armada™ 14 NC PTA CatheterABBOTT MEDICALK251915Amethyst HP PTA OTW 0.035 CatheterNatec 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.K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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