Cleared Traditional

K113103 - SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANG...

K113103 is an FDA 510(k) clearance for SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANG..., manufactured by Rex Medical. The device is a Class 2 Cardiovascular device with product code PNO cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K113103 · Rex Medical · Cardiovascular device
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May 2012
Decision
216d
Days
Class 2
Risk

K113103 is an FDA 510(k) clearance for the SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE. Classified as Catheter, Percutaneous, Cutting/scoring (product code PNO), Class II - Special Controls.

Submitted by Rex Medical (Great Neck, US). The FDA issued a Cleared decision on May 22, 2012 after a review of 216 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 Rex Medical devices

FDA 510(k) Submission Details - K113103

510(k) Number K113103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2011
Decision Date May 22, 2012
Days to Decision 216 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
91d slower than avg
Panel avg: 125d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PNO Device Classification - Class 2, Special Controls

Product Code PNO Catheter, Percutaneous, Cutting/scoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Reduce Vascular Stenosis By Dilatation And Apposition Of The Cutting/scoring Surfaces To The Stenotic Material
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 - PNO Catheter, Percutaneous, Cutting/scoring

All 21
Devices cleared under the same product code (PNO) and FDA review panel - the closest regulatory comparables to K113103.
Scoreflex PTA Scoring Balloon Catheter
K182713 · Orbusneich Medical Trading, Inc. · Jun 2019
UltraScore Focused Force PTA Balloon
K163420 · Bard Peripheral Vascular, Inc. · Jun 2017
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
K141322 · Cook Incorporated · Mar 2015
VASCUTRAK PTA DILATATION CATHETER
K103459 · C.R. Bard, Inc. · Dec 2010
2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS
K070951 · Boston Scientific · Jun 2007
SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM
K062387 · Boston Scientific · Oct 2006