Cleared Traditional

K182713 - Scoreflex PTA Scoring Balloon Catheter

K182713 is the FDA 510(k) clearance for Scoreflex PTA Scoring Balloon Catheter by Orbusneich Medical Trading, Inc.. It is a Class 2 Cardiovascular device (product code PNO) cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K182713 · Orbusneich Medical Trading, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
257d
Days
Class 2
Risk

K182713 is an FDA 510(k) clearance for the Scoreflex PTA Scoring Balloon Catheter. Classified as Catheter, Percutaneous, Cutting/scoring (product code PNO), Class II - Special Controls.

Submitted by Orbusneich Medical Trading, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on June 11, 2019 after a review of 257 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 Orbusneich Medical Trading, Inc. devices

Submission Details

510(k) Number K182713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2018
Decision Date June 11, 2019
Days to Decision 257 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
132d slower than avg
Panel avg: 125d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 20
Devices cleared under the same product code (PNO) and FDA review panel - the closest regulatory comparables to K182713.
FLEX Vessel Prep System
K202187 · Venturemed Group, Inc. · Sep 2020
XO Score Percutaneous Transluminal Angioplasty Scoring Catheter
K193495 · Transit Scientific · May 2020
Serranator PTA Serration Balloon Catheter
K193181 · Cagent Vascular, LLC · Apr 2020
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