Cleared Special

Serranator PTA Serration Balloon Catheter (K213728) - FDA 510(k) Clearance

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

K213728 · Cagent Vascular, LLC · Cardiovascular device
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Dec 2021
Decision
19d
Days
Class 2
Risk

K213728 is an FDA 510(k) clearance for the Serranator PTA Serration Balloon Catheter. Classified as Catheter, Percutaneous, Cutting/scoring (product code PNO), Class II - Special Controls.

Submitted by Cagent Vascular, LLC (Wayne, US). The FDA issued a Cleared decision on December 15, 2021 after a review of 19 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cagent Vascular, LLC devices

Submission Details

510(k) Number K213728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2021
Decision Date December 15, 2021
Days to Decision 19 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
106d faster than avg
Panel avg: 125d · This submission: 19d
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 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 K213728.
D·Kutting™ PTA Scoring Balloon Dilatation Catheter
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XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter
K221986 · Transit Scientific, LLC · Oct 2022
Serranator PTA Serration Balloon Catheter
K220704 · Cagent Vascular, LLC · May 2022
Serranator PTA Serration Balloon Catheter
K203437 · Cagent Vascular, LLC · Dec 2020
FLEX Vessel Prep System
K202187 · Venturemed Group, Inc. · Sep 2020
XO Score Percutaneous Transluminal Angioplasty Scoring Catheter
K193495 · Transit Scientific · May 2020