LogoFDA 510(k) Search
K Number
K113112
Device Name
CLEARWAY RX NB CATHETER
Manufacturer
ATRIUM MEDICAL CORP.
Date Cleared
2011-11-17

(28 days)

Product Code
DQY
Regulation Number
870.1250
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ClearWay™ RX NB is indicated for localized infusion or irrigation of various diagnostic and therapeutic agents into the coronary and peripheral vasculature. It is not indicated for use in the neurovasculature.

Device Description

Not Found

AI/ML Overview

The provided text is a letter from the FDA regarding a 510(k) premarket notification for the "Atrium ClearWay™ RX NB Catheter." This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Instead, it:

  • Confirms that the device is substantially equivalent to legally marketed predicate devices.
  • States that the device is a Class II medical device.
  • Lists the product's indications for use.
  • Outlines FDA regulations and compliance information.

Therefore, I cannot provide the requested information based on the input document.

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).