FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T)

• K Number: K973216
• Device Name: FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T)
• Manufacturer: RMDS, INC.
• Date Cleared: 1997-11-25 ( 90 days)
• Product Code: DXC
• Regulation Number: 870.4450
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

The FAVC-HH: Femoral Artery Vascular Clamp-Hand Held is used to provide pressure hemostasis after the removal of arterial catheters following femoral catherterization procedures. The FAVC-HH: Femoral Artery Vascular Clamp-Hand Held is positioned prior to removal of femoral catheters and applies controlled pressure to the puncture site until hemostasis is complete.

Device Description

FAVC-HH: Femoral Artery Vascular Clamp-Hand Held

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Femoral Artery Vascular Clamp-Hand Held (FAVC-HH)". This document focuses on regulatory approval and does not contain information about acceptance criteria, device performance studies, or clinical trial data as requested in your prompt.

Therefore, I cannot provide the requested information based on the given input. The document confirms that the device is substantially equivalent to previously marketed devices and outlines regulatory requirements, but it does not detail the scientific studies or performance metrics for the FAVC-HH.

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).