Cleared Traditional

OPN NC PTCA Dilatation Catheter (K212393) - FDA 510(k) Clearance

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

K212393 · Sis Medical AG · Cardiovascular device
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Mar 2022
Decision
224d
Days
Class 2
Risk

K212393 is an FDA 510(k) clearance for the OPN NC PTCA Dilatation Catheter. Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Sis Medical AG (Frauenfeld, CH). The FDA issued a Cleared decision on March 14, 2022 after a review of 224 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 Sis Medical AG devices

Submission Details

510(k) Number K212393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2021
Decision Date March 14, 2022
Days to Decision 224 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
99d slower than avg
Panel avg: 125d · This submission: 224d
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 Consultant

Cardiomed Device Consultants
H. Semih Oktay

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 - LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

All 46
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K212393.
NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter
K222538 · Sino Medical Sciences Technology, Inc. · Dec 2022
NC TREK NEO Coronary Dilatation Catheter
K220634 · Abbott Vascular · Jun 2022
Emerge Monorail PTCA Dilatation Catheter
K220629 · Boston Scientific · Mar 2022
Selebrek PTCA Balloon Dilatation Catheter
K211349 · Kossel Medtech (Suzhou) Co., Ltd. · Jan 2022
Sapphire NC 24
K211807 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Oct 2021
Tamarin Blue PTCA RX Dilatation Catheter
K210012 · Natec Medical , Ltd. · Jul 2021