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FDA 510(k)

SABER .035 PTA Dilatation Catheter

K-Number: K201333 · 2020-09-11

ApplicantCordis Corporation
Decision Date2020-09-11
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SABER .035 PTA Dilatation Catheter is a medical device manufactured by Cordis Corporation. It received FDA 510(k) clearance on 2020-09-11 under approval number K201333. 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 SABER .035 PTA Dilatation Catheter?

SABER .035 PTA Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2020-09-11. It is manufactured by Cordis Corporation. The 510(k) number is K201333.

When was SABER .035 PTA Dilatation Catheter approved by the FDA?

SABER .035 PTA Dilatation Catheter received FDA 510(k) clearance on 2020-09-11, under approval number K201333.

What company makes SABER .035 PTA Dilatation Catheter?

SABER .035 PTA Dilatation Catheter is manufactured by Cordis Corporation.

What is the FDA product code for SABER .035 PTA Dilatation Catheter?

The FDA product code for SABER .035 PTA Dilatation Catheter is LIT.

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Related Devices (Code: LIT)

K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K162316Pirouette 014Arravasc, Ltd. K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018Boston Scientific Corporation K161427Pirouette 035Arravasc Limited K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K160004Crosstella OTWKANEKA Corporation

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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