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 a medical device manufactured by Cordis Corporation. It received FDA 510(k) clearance on 2020-10-09 under approval 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. It is manufactured by Cordis Corporation. The 510(k) number is K201377.
When was SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter approved by the FDA?
SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter received FDA 510(k) clearance on 2020-10-09, under approval number K201377.
What company makes SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter?
SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter is manufactured by Cordis Corporation.
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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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.