Cleared Traditional

K243944 - Aperta NSE PTA Balloon Dilatation Catheter (FDA 510(k) Clearance)

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

K243944 · Goodman Co., Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2025
Decision
123d
Days
Class 2
Risk

K243944 is an FDA 510(k) clearance for the Aperta NSE PTA Balloon Dilatation Catheter. Classified as Catheter, Percutaneous, Cutting/scoring (product code PNO), Class II - Special Controls.

Submitted by Goodman Co., Ltd. (Nagoya, JP). The FDA issued a Cleared decision on April 22, 2025 after a review of 123 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 Goodman Co., Ltd. devices

Submission Details

510(k) Number K243944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2024
Decision Date April 22, 2025
Days to Decision 123 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
2d faster than avg
Panel avg: 125d · This submission: 123d
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

Infraredx
Nozomi Yagi

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 44
Devices cleared under the same product code (PNO) and FDA review panel - the closest regulatory comparables to K243944.
UltraScore™ Focused Force PTA Balloon
K260012 · Bard Peripheral Vascular, Inc. · Feb 2026
D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter
K242254 · Dk Medical Technology Co., Ltd. · Apr 2025
Tri-Wedge PTA Scoring Balloon Dilatation Catheter
K241478 · Brosmed Medical Co., Ltd. · Oct 2024
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