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FDA 510(k)

Cronus HP PTA Balloon Catheter

K-Number: K190037 · 2019-10-24

ApplicantNipro Medical Corporation
Decision Date2019-10-24
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cronus HP PTA Balloon Catheter is a medical device manufactured by Nipro Medical Corporation. It received FDA 510(k) clearance on 2019-10-24 under approval number K190037. 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 Cronus HP PTA Balloon Catheter?

Cronus HP PTA Balloon Catheter is a medical device that received FDA 510(k) clearance on 2019-10-24. It is manufactured by Nipro Medical Corporation. The 510(k) number is K190037.

When was Cronus HP PTA Balloon Catheter approved by the FDA?

Cronus HP PTA Balloon Catheter received FDA 510(k) clearance on 2019-10-24, under approval number K190037.

What company makes Cronus HP PTA Balloon Catheter?

Cronus HP PTA Balloon Catheter is manufactured by Nipro Medical Corporation.

What is the FDA product code for Cronus HP PTA Balloon Catheter?

The FDA product code for Cronus HP PTA Balloon Catheter is LIT.

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Other Devices by Nipro Medical Corporation

K151141Cronus HP - High Pressure Peripheral Balloon Catheter K161681Nipro SafeTouch IV Catheter K160444FB-U Hemodialyzer K173029Nipro Syringe K191359Nipro Syringe K182940Surdial DX Hemodialysis System

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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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