FDA 510(k)

SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter

K-Number: K210626 · 2021-04-23

Decision Date2021-04-23

Product CodeLIT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a medical device manufactured by Cordis Corporation. It received FDA 510(k) clearance on 2021-04-23 under approval number K210626. 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 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter?

SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2021-04-23. It is manufactured by Cordis Corporation. The 510(k) number is K210626.

When was SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter approved by the FDA?

SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter received FDA 510(k) clearance on 2021-04-23, under approval number K210626.

What company makes SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter?

SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is manufactured by Cordis Corporation.

What is the FDA product code for SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter?

The FDA product code for SABER .035 Percutaneous Transluminal Angioplasty (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

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