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K Number
K061484
Device Name
MODIFICATION TO: SMITHWICK CAROTID SHUNT
Manufacturer
MCPHERSON ENTERPRISES, INC.
Date Cleared
2006-12-07

(191 days)

Product Code
DXC
Regulation Number
870.4450
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Smithwick Carotid Shunt intended use is for a carotid endanterectomy procedure. The Doppler crystal built into the shunt provides for Audible verification of blood flow during carotid endarterestomy.

Device Description

Smithwick Doppler and Non-Doppler Carotid Shunt

AI/ML Overview

This document is a letter from the FDA regarding the 510(k) premarket notification for the "Smithwick Carotid Shunt," and it does not contain information about acceptance criteria or a study proving device performance.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence to existing predicate devices, rather than detailed performance study results.

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).