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K Number
K042308
Device Name
SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019
Manufacturer
FACILE MEDICAL, INC.
Date Cleared
2005-02-17

(176 days)

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

The Sheath-in 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

I am sorry, but the provided text does not contain any information about the acceptance criteria or a study that proves a device meets such criteria. The document is primarily a 510(k) clearance letter from the FDA for a medical device called the "Sheath-in-Sheath Catheter."

It discusses:

  • The FDA's review and determination of substantial equivalence for the device.
  • Regulatory requirements and guidelines.
  • The intended use of the device.

There is no mention of specific acceptance criteria (e.g., performance metrics, thresholds), a study design, sample sizes, expert qualifications, adjudication methods, or ground truth establishment for a device's performance. Therefore, I cannot extract the information you requested to fill out the table and answer your questions.

§ 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).