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FDA 510(k)

SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter

K-Number: K221832 · 2022-08-22

ApplicantCordis US Corp
Decision Date2022-08-22
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter is a medical device manufactured by Cordis US Corp. It received FDA 510(k) clearance on 2022-08-22 under approval number K221832. 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 .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter?

SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-08-22. It is manufactured by Cordis US Corp. The 510(k) number is K221832.

When was SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter approved by the FDA?

SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter received FDA 510(k) clearance on 2022-08-22, under approval number K221832.

What company makes SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter?

SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter is manufactured by Cordis US Corp.

What is the FDA product code for SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter?

The FDA product code for SABER .014 PTA Dilatation Catheter; SABERX .014 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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