LogoFDA 510(k) Search
K Number
K001621

Validate with FDA (Live)

Device Name
DARDIK CAROTID SHUNT
Manufacturer
VASCUTECH, INC.
Date Cleared
2000-12-06

(194 days)

Product Code
MJN
Regulation Number
870.4450
Type
Traditional
Panel
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

Loading...

§ 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).