FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M200) FAVC-M FEMORAL ARTERY VASCULAR CLAMP-MOBILE ADJ BELT 6005

• K Number: K970027
• Device Name: FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M200) FAVC-M FEMORAL ARTERY VASCULAR CLAMP-MOBILE ADJ BELT 6005
• Manufacturer: RMDS, INC.
• Date Cleared: 1997-08-08 ( 217 days)
• Product Code: DXC
• Regulation Number: 870.4450
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

Femoral Artery Vascular Clamp-Mobile is used to provide pressure hemostasis after the removal of arterial catheters following femoral catheterization procedures. The FAVC-M: Femoral Artery Vascular Clamp-Mobile is positioned prior to removal of femoral catheters and apply controlled pressure to the puncture site until hemostasis is complete.

Device Description

FAVC-M: Femoral Artery Vascular Clamp-Mobile

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "FAVC-M: Femoral Artery Vascular Clamp-Mobile". It is a regulatory approval document and does not contain information about the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information.

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).