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Tamarin Blue PTCA RX Dilatation Catheter

by Natec Medical Ltd 2 variants

510(k) K210012

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK210012 Date9 Jul 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LOX
FDA applicant
Natec Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.5100
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Tamarin Blue PTCA RX Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, designed for balloon dilatation of stenotic coronary arteries or bypass graft stenosis. It is a rapid exchange (RX) device used to improve myocardial perfusion during interventional cardiology procedures.

This catheter is supplied as a single-use, non-sterile device (sterilised prior to use) and is classified as a Class II medical device under FDA regulations (product code LOX). It is intended for use in cardiac catheterisation laboratories and has received FDA 510(k) clearance through the Special pathway. Available in various sizes, it must be handled and stored according to manufacturer instructions to maintain integrity.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Tamarin Blue PTCA RX Dilatation Catheter used for in clinical practice?

    The Tamarin Blue PTCA RX Dilatation Catheter is specifically designed for balloon dilatation of stenotic coronary arteries or bypass graft stenosis during interventional cardiology procedures. It is intended to improve myocardial perfusion by widening narrowed or blocked vessels, making it suitable for use in cardiac catheterization laboratories.

  • Is the Tamarin Blue PTCA RX Dilatation Catheter single-use or reusable, and how should it be handled?

    The Tamarin Blue PTCA RX Dilatation Catheter is a single-use device, though it is supplied in a non-sterile state and must be sterilized prior to use. It is critical to follow the manufacturer’s instructions for sterilization and handling to ensure device integrity and safety.

  • What type of regulatory clearance does the Tamarin Blue PTCA RX Dilatation Catheter have, and how was it obtained?

    The Tamarin Blue PTCA RX Dilatation Catheter has received FDA 510(k) clearance through the Special pathway, which is used for devices that are substantially equivalent to a predicate device already on the market. The clearance was granted by the FDA’s Cardiovascular (CV) advisory committee.

  • Are there different sizes available for the Tamarin Blue PTCA RX Dilatation Catheter, and how should it be stored?

    Yes, the Tamarin Blue PTCA RX Dilatation Catheter is available in various sizes to accommodate different clinical needs. Storage instructions must be strictly followed to maintain the device’s integrity, as improper handling could compromise its performance.