Cleared Traditional

K182713 - Scoreflex PTA Scoring Balloon Catheter

K182713 is an FDA 510(k) clearance for Scoreflex PTA Scoring Balloon Catheter, manufactured by Orbusneich Medical Trading, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K182713

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.

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 34
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
K172571 · C. R. Bard · Sep 2017
UltraScore Focused Force PTA Balloon
K163420 · Bard Peripheral Vascular, Inc. · Jun 2017
Serranator Alto PTA Serration Balloon Catheter
K163380 · Cagent Vascular, LLC · Feb 2017