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K Number
K050684
Device Name
ATLANTIS PV
Manufacturer
BOSTON SCIENTIFIC CORP.
Date Cleared
2005-05-20

(64 days)

Product Code
DQO
Regulation Number
870.1200
Type
Special
Panel
RA
Reference & Predicate Devices
K050064
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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

This document is a 510(k) clearance letter from the FDA for the Atlantis™ PV Imaging Catheter and does not contain information about acceptance criteria or a study proving that the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than performance data.

§ 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).