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K Number
K093431
Device Name
CLEARWAY OTW MODEL 85912
Manufacturer
ATRIUM MEDICAL CORP.
Date Cleared
2010-04-20

(167 days)

Product Code
DQY,DOY
Regulation Number
870.1250
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For localized infusion or irrigation of various diagnostic and therapeutic agents into the peripheral vasculature. It is not indicated for use in the neurovasculature.

Device Description

ClearWay OTW catheter

AI/ML Overview

I apologize, but the provided text is a 510(k) clearance letter from the FDA for the Atrium Medical Corp. ClearWay OTW catheter. This document primarily focuses on regulatory approval based on "substantial equivalence" to a predicate device and does not contain information about acceptance criteria or specific study data to prove the device meets those criteria.

Therefore, I cannot extract the requested information, such as acceptance criteria tables, sample sizes, expert qualifications, or details about standalone or MRMC studies, because this information is not present in the provided text. The document is a regulatory approval notice, not a clinical study report or a technical performance specification.

§ 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).