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K Number
K001856
Device Name
SUPERCROSS CATHETER
Manufacturer
ABBOTT VASCULAR INC.
Date Cleared
2001-03-07

(261 days)

Product Code
DQY
Regulation Number
870.1250
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
K014118
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).