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K Number
K053300
Device Name
SYVEKEXCEL
Manufacturer
MARINE POLYMER TECHNOLOGIES, INC.
Date Cleared
2006-03-28

(123 days)

Product Code
DXC
Regulation Number
870.4450
Type
Traditional
Panel
CV
Reference & Predicate Devices
K984177,K040615,K030836,K050146,K973132,K024107,K964663,K021062
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Syvekexcel® Vascular Access Hemostasis System is intended for use following femoral vascular catheterization procedures to assist in obtaining and maintaining hemostasis.

Device Description

Syvekexed® Vascular Access Hemostasis System consists of four (4) components in a kit:

    1. a Syvekexcel® Patch 3 cm x 4cm lyophilized pad of poly-N-acetylglucosamine with foam backing,
  • a disposable Polypropylene support structure, which snaps on to component 3, 2.
    1. a reusable Plexiglas handle, and
    1. a Tegaderm® transparent adhesive bandage
      Syvekexcel® Vascular Access Hemostasis System is used to apply direct pressure to obtain and maintain hemostasis, in a similar fashion to direct manual pressure on the access site or at a pressure point. After hemostasis has been achieved the Syvekexcel® Patch is covered with the Tegaderm transparent adhesive bandage.
AI/ML Overview

This document is a 510(k) summary for the Syvekexcel Vascular Access Hemostasis System, seeking substantial equivalence to predicate devices. It describes the device, its intended use, and claims substantial equivalence based on scientific testing. However, it does not contain any information about acceptance criteria or the specifics of a study evaluating the device's performance against such criteria.

Therefore, I cannot fulfill your request for the tables and study details. The provided text primarily focuses on the regulatory submission process and the declaration of substantial equivalence, rather than presenting a performance study against specific acceptance criteria.

To answer your questions, I would need a document that includes performance data, defined acceptance criteria, details about the study design (sample size, ground truth, experts, adjudication), and potentially a comparative effectiveness study. This K053300 submission does not provide that level of detail.

§ 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).