Cleared Traditional

K171251 - 014 Hydrophilic Coated PTA Balloon Dila...

K171251 is an FDA 510(k) clearance for 014 Hydrophilic Coated PTA Balloon Dila..., manufactured by Creagh Medical. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K171251 · Creagh Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
133d
Days
Class 2
Risk

K171251 is an FDA 510(k) clearance for the 014 Hydrophilic Coated PTA Balloon Dilatation Catheter. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Creagh Medical (Ballinasloe, IE). The FDA issued a Cleared decision on September 8, 2017 after a review of 133 days - within the typical 510(k) review window.

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 Creagh Medical devices

FDA 510(k) Submission Details - K171251

510(k) Number K171251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2017
Decision Date September 08, 2017
Days to Decision 133 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 125d · This submission: 133d
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 278
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K171251.
Admiral Xtreme
K173515 · Medtronic Vascular · Apr 2018
Jade PTA Balloon Dilatation Catheter
K173894 · Orbusneich Medical Trading, Inc. · Feb 2018
Advocate PTA Catheter
K173621 · Merit Medical Systems, Inc. · Dec 2017
Advance 14LP Low Profile PTA Balloon Dilatation Catheter
K170193 · Cook Incorporated · Feb 2017
Coyote 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 0.018
K162350 · Boston Scientific Corporation · Nov 2016
Cronus HP - High Pressure Peripheral Balloon Catheter
K151141 · Nipro Medical Corporation · Jan 2016