Cleared Special

XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter (K221986) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K221986 · Transit Scientific, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
104d
Days
Class 2
Risk

K221986 is an FDA 510(k) clearance for the XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score .... Classified as Catheter, Percutaneous, Cutting/scoring (product code PNO), Class II - Special Controls.

Submitted by Transit Scientific, LLC (Salt Lake City, US). The FDA issued a Cleared decision on October 18, 2022 after a review of 104 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Transit Scientific, LLC devices

Submission Details

510(k) Number K221986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2022
Decision Date October 18, 2022
Days to Decision 104 days
Submission Type Special
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
21d faster than avg
Panel avg: 125d · This submission: 104d
Pathway characteristics
Modification to existing cleared device.

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
Spencer Walker

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 17
Devices cleared under the same product code (PNO) and FDA review panel - the closest regulatory comparables to K221986.
XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter
K232258 · Transit Scientific, LLC · Jun 2024
Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)
K232013 · Goodman Co., Ltd. · Mar 2024
D·Kutting™ PTA Scoring Balloon Dilatation Catheter
K232207 · Dk Medical Technology Co., Ltd. · Mar 2024
Serranator PTA Serration Balloon Catheter
K220704 · Cagent Vascular, LLC · May 2022
Serranator PTA Serration Balloon Catheter
K213728 · Cagent Vascular, LLC · Dec 2021
Serranator PTA Serration Balloon Catheter
K203437 · Cagent Vascular, LLC · Dec 2020