Cleared Traditional

K151141 - Cronus HP - High Pressure Peripheral Balloon Catheter

K151141 is an FDA 510(k) clearance for Cronus HP - High Pressure Peripheral Ba..., 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 260-day FDA review.

K151141 · Nipro Medical Corporation · Cardiovascular device
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Jan 2016
Decision
260d
Days
Class 2
Risk

K151141 is an FDA 510(k) clearance for the Cronus HP - High Pressure Peripheral 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 January 14, 2016 after a review of 260 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 - K151141

510(k) Number K151141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2015
Decision Date January 14, 2016
Days to Decision 260 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
135d slower than avg
Panel avg: 125d · This submission: 260d
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 346
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K151141.
MMS PTA Balloon Catheter
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Crosstella RX Balloon Dilatation Catheter
K152873 · KANEKA Corporation · Jan 2016
Crosperio RX PTA Balloon Dilatation Catheter
K152887 · KANEKA Corporation · Jan 2016
PolarCath Peripheral Dilatation System
K152665 · Nucyro Vascular, LLC · Oct 2015
Passeo-18 Peripheral Dilation Catheter
K151744 · Biotronik, Inc. · Oct 2015
Passeo-14 Peripheral Dilatation Catheter
K152240 · Biotronik, Inc. · Oct 2015