ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER

• K Number: K061680
• Device Name: ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER
• Manufacturer: ATRIUM MEDICAL CORP.
• Date Cleared: 2006-12-15 ( 183 days)
• Product Code: DQY
• Regulation Number: 870.1250
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Atrium ClearWay™ RX Catheter 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 510(k) clearance letter from the FDA for the Atrium ClearWay™ RX Catheter. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information. The text is limited to regulatory clearance and does not delve into the technical validation or performance studies of the device.

Regulation Number and Section

§ 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).