THE HAMMER MODEL H100

• K Number: K012041
• Device Name: THE HAMMER MODEL H100
• Manufacturer: TENACORE HOLDINGS, INC.
• Date Cleared: 2002-03-28 ( 272 days)
• Product Code: DXC
• Regulation Number: 870.4450
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

Indicated in the compression of the femoral artery or vein after catherization.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for a medical device called "The Hammer, Model H100," a vascular clamp. This type of document is a regulatory approval notice and typically does not contain the kind of detailed study information requested in your prompt (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.).

The letter confirms that the FDA reviewed the premarket notification and found the device substantially equivalent to legally marketed predicate devices for its stated indications for use: "Indicated in the compression of the femoral artery or vein after catheterization."

Therefore, I cannot provide the requested information from the provided text. The document is solely an approval letter based on a substantial equivalence finding, not a clinical study report.

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).