Cleared Traditional

K241478 - Tri-Wedge PTA Scoring Balloon Dilatatio...

K241478 is an FDA 510(k) clearance for Tri-Wedge PTA Scoring Balloon Dilatatio..., manufactured by Brosmed Medical Co., Ltd.. The device is a Class 2 Cardiovascular device with product code PNO cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K241478 · Brosmed Medical Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
151d
Days
Class 2
Risk

K241478 is an FDA 510(k) clearance for the Tri-Wedge PTA Scoring Balloon Dilatation Catheter. Classified as Catheter, Percutaneous, Cutting/scoring (product code PNO), Class II - Special Controls.

Submitted by Brosmed Medical Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on October 22, 2024 after a review of 151 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 Brosmed Medical Co., Ltd. devices

FDA 510(k) Submission Details - K241478

510(k) Number K241478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2024
Decision Date October 22, 2024
Days to Decision 151 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
26d slower than avg
Panel avg: 125d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PNO Device Classification - Class 2, Special Controls

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 20
Devices cleared under the same product code (PNO) and FDA review panel - the closest regulatory comparables to K241478.
UltraScore™ Focused Force PTA Balloon
K260012 · Bard Peripheral Vascular, Inc. · Feb 2026
Aperta NSE PTA Balloon Dilatation Catheter
K243944 · Goodman Co., Ltd. · Apr 2025
D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter
K242254 · Dk Medical Technology Co., Ltd. · Apr 2025
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