SMITHWICK CAROTID SHUNT

• K Number: K021608
• Device Name: SMITHWICK CAROTID SHUNT
• Manufacturer: IMPLANTABLE DEVICES
• Date Cleared: 2002-10-22 ( 159 days)
• Product Code: DXC
• Regulation Number: 870.4450
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Carotid Shunt is intended to be used in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the Smithwick Carotid Shunt. It primarily focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot extract the requested information from the provided text. The letter only confirms that the device can be legally marketed following FDA review, but it does not detail the specific data or studies that led to that determination.

Regulation Number and Section

§ 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).