LogoFDA 510(k) Search
K Number
K003925
Device Name
PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS
Manufacturer
CORDIS NEUROVASCULAR, INC.
Date Cleared
2001-01-08

(19 days)

Product Code
KRA
Regulation Number
870.1210
Type
Special
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).