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FDA 510(k)

Jade PTA Balloon Dilatation Catheter

K-Number: K173894 · 2018-02-09

ApplicantOrbusneich Medical Trading, Inc.
Decision Date2018-02-09
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Jade PTA Balloon Dilatation Catheter is a medical device manufactured by Orbusneich Medical Trading, Inc.. It received FDA 510(k) clearance on 2018-02-09 under approval number K173894. 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 Jade PTA Balloon Dilatation Catheter?

Jade PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2018-02-09. It is manufactured by Orbusneich Medical Trading, Inc.. The 510(k) number is K173894.

When was Jade PTA Balloon Dilatation Catheter approved by the FDA?

Jade PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2018-02-09, under approval number K173894.

What company makes Jade PTA Balloon Dilatation Catheter?

Jade PTA Balloon Dilatation Catheter is manufactured by Orbusneich Medical Trading, Inc..

What is the FDA product code for Jade PTA Balloon Dilatation Catheter?

The FDA product code for Jade PTA Balloon Dilatation Catheter is LIT.

Related Clinical Trials

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Other Devices by Orbusneich Medical Trading, Inc.

K182360Teleport Microcatheter K180921Sapphire II PRO Balloon Dilatation Catheter K173680Sapphire II PRO K192344Sapphire NC Plus Coronary Dilatation Catheter K182713Scoreflex PTA Scoring Balloon Catheter K200269Sapphire II PRO

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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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