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K Number
K030734
Device Name
PATHWAY ACCESS SHEATH CATHETER
Manufacturer
VERTELINK CORPORATION
Date Cleared
2003-09-10

(184 days)

Product Code
DYB
Regulation Number
870.1340
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Pathway™ Access Sheath Catheter is designed to facilitate the entry of interventional devices into the vessels of the cardiovascular system.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for the Vertelink Corporation's Pathway Access Sheath Catheter. This type of document declares that a medical device is substantially equivalent to a predicate device already on the market and does not contain the detailed information necessary to answer the questions about acceptance criteria and study design for an AI/CADe device.

Specifically, the document does not include:

  • A table of acceptance criteria and reported device performance.
  • Information about sample sizes for test sets or data provenance.
  • Details about experts or ground truth establishment.
  • Adjudication methods.
  • Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone performance.
  • Information on training set size or how its ground truth was established.

This document is a regulatory approval, not a scientific study report.

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).