LogoFDA 510(k) Search
K Number
K953133
Device Name
SCIMED DISPATCH CORONARY INFUSION CATHETER
Manufacturer
SCIMED LIFE SYSTEMS, INC.
Date Cleared
1996-02-23

(232 days)

Product Code
KRA
Regulation Number
870.1210
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).