Cleared Traditional

HP PTA Balloon Dilatation Catheter (K231402) - FDA 510(k) Clearance

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

K231402 · Kossel Medtech (Suzhou) Co., Ltd. · Cardiovascular device
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Dec 2023
Decision
219d
Days
Class 2
Risk

K231402 is an FDA 510(k) clearance for the HP PTA Balloon Dilatation Catheter. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Kossel Medtech (Suzhou) Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on December 20, 2023 after a review of 219 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 Kossel Medtech (Suzhou) Co., Ltd. devices

Submission Details

510(k) Number K231402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2023
Decision Date December 20, 2023
Days to Decision 219 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
94d slower than avg
Panel avg: 125d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 154
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K231402.
Oscar Peripheral Multifunctional Catheter system
K241711 · Biotronik, Inc. · Jul 2024
Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 )
K241683 · Boston Scientific Corporation · Jul 2024
JADE PLUS PTA Balloon Dilatation Catheter
K241025 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Jun 2024
Finesse™ Injectable PTA Balloon Dilatation Catheter
K230263 · Summa Therapeutics, LLC · May 2023
D·Kaptain PTA High Pressure Balloon Dilatation Catheter
K214009 · Dk Medical Technology Co., Ltd. · Apr 2023
Arise™ UHP Dilatation Catheter
K230191 · Creagh Medical, Ltd. · Mar 2023