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K Number
K012574
Device Name
REPROCESSED FEMORAL COMPRESSION DEVICE
Manufacturer
STERILMED, INC.
Date Cleared
2002-07-18

(343 days)

Product Code
NMF
Regulation Number
870.4450
Type
Traditional
Panel
CV
Reference & Predicate Devices
K915280
Predicate For
K120204
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The reprocessed femoral compression device is intended for use in the compression of the femoral artery or vein after catheterization.

Device Description

Reprocessed Femoral Compression Device

AI/ML Overview

This document is a 510(k) premarket notification for a reprocessed femoral compression device. It details the device, its intended use, and claims of substantial equivalence to an existing device. However, it does not contain any information about acceptance criteria, device performance, study design, or ground truth establishment relevant to the questions provided. The document is a regulatory submission for market clearance, not a study report detailing performance metrics.

Therefore, I cannot answer the questions based on the provided text. The requested information on acceptance criteria, study details, sample sizes, expert involvement, and ground truth are not present in this regulatory submission.

§ 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).