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510(k) Data Aggregation
K Number
K113112Device Name
CLEARWAY RX NB CATHETERManufacturer
Date Cleared
2011-11-17
(28 days)
Product Code
Regulation Number
870.1250Type
SpecialPanel
Cardiovascular (CV)Reference & Predicate Devices
N/A
Why did this record match?
Device Name :
CLEARWAY RX NB CATHETER
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.
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