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K Number
K003169
Device Name
VASCULAR CLOSURE DEVICE
Manufacturer
STD MFG., INC.
Date Cleared
2000-12-08

(59 days)

Product Code
GDW
Regulation Number
878.4750
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 878.4750 Implantable staple.

(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.