MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456

• K Number: K041727
• Device Name: MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456
• Manufacturer: BOSTON SCIENTIFIC SCIMED, INC.
• Date Cleared: 2004-07-23 ( 28 days)
• Product Code: OBJ
• Regulation Number: 870.1200
• Type: Special
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

The Atlantis™ PV Imaging Catheter is intended for ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "Atlantis PV Imaging Catheter" and focuses on regulatory approval based on substantial equivalence to a predicate device. It does not include details on acceptance criteria, a specific study proving device performance, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device as outlined in your prompt.

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).