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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 the device name listed in this FDA 510(k) record. The listed applicant is Nipro Medical Corporation. It received FDA 510(k) clearance on 2019-10-24 under 510(k) 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. The listed applicant is Nipro Medical Corporation. The 510(k) number is K190037.

When did Cronus HP PTA Balloon Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Cronus HP PTA Balloon Catheter?

The FDA 510(k) record lists Nipro Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

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 records listing Nipro Medical Corporation as applicant

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Related Devices (Code: LIT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260304WAVE PTA Balloon CatheterWAVE Medical AGK252512Armada™ 14 NC PTA CatheterABBOTT MEDICALK251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, Inc.K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.

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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