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K Number
K980282
Device Name
URESIL DILATOR WITH RADIOPAQUE MARKER
Manufacturer
URESIL CORP.
Date Cleared
1998-04-24

(88 days)

Product Code
DRE
Regulation Number
870.1310
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This device is intended to help create a tract for catheter insertion.

Device Description

Not Found

AI/ML Overview

This is a 510(k) summary and not a study. It does not provide the information requested to describe acceptance criteria and study proving device meets the criteria.

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).