Cleared Traditional

K190037 - Cronus HP PTA Balloon Catheter

K190037 is an FDA 510(k) clearance for Cronus HP PTA Balloon Catheter, manufactured by Nipro Medical Corporation. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K190037 · Nipro Medical Corporation · Cardiovascular device
Download Printable Device Report (PDF)
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Oct 2019
Decision
289d
Days
Class 2
Risk

K190037 is an FDA 510(k) clearance for the Cronus HP PTA Balloon Catheter. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on October 24, 2019 after a review of 289 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Nipro Medical Corporation devices

FDA 510(k) Submission Details - K190037

510(k) Number K190037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2019
Decision Date October 24, 2019
Days to Decision 289 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 125d · This submission: 289d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIT Device Classification - Class 2, Special Controls

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 347
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K190037.
Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter
K200700 · Creagh Medical, Ltd. · May 2020
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K191275 · Nexstep Medical · Jan 2020
Advocate PTA Catheter
K192907 · Merit Medical Systems, Inc. · Nov 2019
Ultraverse 014 and 018 PTA Balloon Dilatation Catheters
K192318 · Bard Peripheral Vascular, Inc. · Oct 2019
EverCrossTM 0.035 OTW PTA Dilatation Catheter
K190753 · Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.) · Apr 2019
Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection
K181529 · Contego Medical, LLC · Dec 2018