Cleared Special

Tamarin Blue PTCA RX Dilatation Catheter (K210012) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K210012 · Natec Medical , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
186d
Days
Class 2
Risk

K210012 is an FDA 510(k) clearance for the Tamarin Blue PTCA RX Dilatation Catheter. Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Natec Medical , Ltd. (Reduit, MU). The FDA issued a Cleared decision on July 9, 2021 after a review of 186 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Natec Medical , Ltd. devices

Submission Details

510(k) Number K210012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2021
Decision Date July 09, 2021
Days to Decision 186 days
Submission Type Special
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
61d slower than avg
Panel avg: 125d · This submission: 186d
Pathway characteristics
Modification to existing cleared device.

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, LLC
Candace Cederman

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 43
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K210012.
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Sapphire NC 24
K211807 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Oct 2021
Selethru(TM) NC PTCA Balloon Dilatation Catheter
K211393 · Kossel Medtech (Suzhou) Co., Ltd. · Jul 2021
KardiFlex NC Coronary Dilatation Catheter
K202578 · Medcaptain Life Science Co., Ltd. · May 2021
KardiFlex PTCA Balloon Dilatation Catheter
K202619 · Medcaptain Life Science Co., Ltd. · Apr 2021