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510(k) Data Aggregation
K Number
K050684Device Name
ATLANTIS PVManufacturer
Date Cleared
2005-05-20
(64 days)
Product Code
Regulation Number
870.1200Type
SpecialPanel
RadiologyReference & Predicate Devices
Why did this record match?
Reference Devices :
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.
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