Cleared Traditional

K193495 - XO Score Percutaneous Transluminal Angi...

K193495 is the FDA 510(k) clearance for XO Score Percutaneous Transluminal Angi... by Transit Scientific. It is a Class 2 Cardiovascular device (product code PNO) cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K193495 · Transit Scientific · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
164d
Days
Class 2
Risk

K193495 is an FDA 510(k) clearance for the XO Score Percutaneous Transluminal Angioplasty Scoring Catheter. Classified as Catheter, Percutaneous, Cutting/scoring (product code PNO), Class II - Special Controls.

Submitted by Transit Scientific (Salt Lake City, US). The FDA issued a Cleared decision on May 29, 2020 after a review of 164 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 Transit Scientific devices

Submission Details

510(k) Number K193495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2019
Decision Date May 29, 2020
Days to Decision 164 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
39d slower than avg
Panel avg: 125d · This submission: 164d
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 Consultant

University of Utah
Srividya Pothana

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PNO Catheter, Percutaneous, Cutting/scoring

All 19
Devices cleared under the same product code (PNO) and FDA review panel - the closest regulatory comparables to K193495.
Serranator PTA Serration Balloon Catheter
K213728 · Cagent Vascular, LLC · Dec 2021
Serranator PTA Serration Balloon Catheter
K203437 · Cagent Vascular, LLC · Dec 2020
FLEX Vessel Prep System
K202187 · Venturemed Group, Inc. · Sep 2020
Serranator PTA Serration Balloon Catheter
K193181 · Cagent Vascular, LLC · Apr 2020
Scoreflex PTA Scoring Balloon Catheter
K182713 · Orbusneich Medical Trading, Inc. · Jun 2019
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
K141322 · Cook Incorporated · Mar 2015