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K Number
K032041
Device Name
DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)
Manufacturer
LEMAITRE VASCULAR, INC.
Date Cleared
2003-08-27

(57 days)

Product Code
DWF
Regulation Number
870.4210
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Distal Perfusion Catheter is intended for use as a temporary perfusion conduit to allow blood flow to the distal arteries during open abdominal and thoracoabdominal aortic aneurysm repair.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Distal Perfusion Catheter."

This document does NOT contain the requested information about acceptance criteria, device performance, study details, or ground truth establishment.

The letter primarily:

  • Confirms that the device, a Distal Perfusion Catheter, has been found substantially equivalent to legally marketed predicate devices.
  • States the regulatory class (Class II) and product code (DWF).
  • Outlines general regulatory requirements the manufacturer must adhere to (registration, listing, GMP, labeling, etc.).
  • Provides contact information for further guidance.
  • Includes an "Indications For Use" statement.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).