Cleared Traditional

Serranator PTA Serration Balloon Catheter (K193181) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193181 · Cagent Vascular, LLC · Cardiovascular device
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Apr 2020
Decision
149d
Days
Class 2
Risk

K193181 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 April 15, 2020 after a review of 149 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. 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 Cagent Vascular, LLC devices

Submission Details

510(k) Number K193181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2019
Decision Date April 15, 2020
Days to Decision 149 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
24d slower than avg
Panel avg: 125d · This submission: 149d
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 17
Devices cleared under the same product code (PNO) and FDA review panel - the closest regulatory comparables to K193181.
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
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
VASCUTRAK PTA DILATATION CATHETER
K103459 · C.R. Bard, Inc. · Dec 2010