LogoFDA 510(k) Search
K Number
K083370
Device Name
D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006
Manufacturer
ARTEGRAFT, INC.
Date Cleared
2008-12-12

(28 days)

Product Code
QEW,DXE
Regulation Number
870.5150
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For breaking apart and removing thrombus from hemodialysis access grafts.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the D-Clot Thrombectomy Catheter System. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter merely states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

  • Acceptance criteria and reported device performance
  • Sample size used, data provenance
  • Number of experts or their qualifications
  • Adjudication method
  • MRMC comparative effectiveness study or effect size
  • Standalone performance
  • Type of ground truth used
  • Sample size for training set
  • How ground truth for the training set was established

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).