LEMAITRE OCCLUSION CATHETER

• K Number: K992942
• Device Name: LEMAITRE OCCLUSION CATHETER
• Manufacturer: VASCUTECH, INC.
• Date Cleared: 2000-04-13 ( 226 days)
• Product Code: MJN
• Regulation Number: 870.4450
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

The LeMaitre Occlusion Catheter is indicated for temporary vessel occlusion.

Device Description

Not Found

AI/ML Overview

I am sorry, but this document contains a letter from the FDA to a medical device manufacturer concerning the clearance of a "LeMaitre Occlusion Catheter." It does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, study designs (MRMC, standalone), or ground truth establishment relevant to an AI/ML device.

Therefore, I cannot provide the requested information based on the provided text.

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).