Cleared Traditional

Selebrek PTCA Balloon Dilatation Catheter (K211349) - FDA 510(k) Clearance

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

K211349 · Kossel Medtech (Suzhou) Co., Ltd. · Cardiovascular device
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Jan 2022
Decision
249d
Days
Class 2
Risk

K211349 is an FDA 510(k) clearance for the Selebrek PTCA Balloon Dilatation Catheter. Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Kossel Medtech (Suzhou) Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on January 7, 2022 after a review of 249 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5100 - 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 K211349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2021
Decision Date January 07, 2022
Days to Decision 249 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
124d slower than avg
Panel avg: 125d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5100
Definition A Ptca Catheter Is A Device That Operates On The Principle Of Hydraulic Pressurization Applied Through An Inflatable Balloon Attached To The Distal End.
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 - LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

All 43
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K211349.
NC TREK NEO Coronary Dilatation Catheter
K220634 · Abbott Vascular · Jun 2022
Emerge Monorail PTCA Dilatation Catheter
K220629 · Boston Scientific · Mar 2022
OPN NC PTCA Dilatation Catheter
K212393 · Sis Medical AG · Mar 2022
Sapphire NC 24
K211807 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Oct 2021
Tamarin Blue PTCA RX Dilatation Catheter
K210012 · Natec Medical , Ltd. · Jul 2021
Selethru(TM) NC PTCA Balloon Dilatation Catheter
K211393 · Kossel Medtech (Suzhou) Co., Ltd. · Jul 2021