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K Number
K991259
Device Name
TE ME NA EPIDURAL CATHETER
Manufacturer
TE ME NA S.A.R.L.
Date Cleared
2001-02-21

(680 days)

Product Code
BSO
Regulation Number
868.5120
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Te me na Polymedic Epidural Anesthesia Catheter is intended for administration of local anesthetic and/or analgesic solutions into the epidural or Caudal space for up to 72 hours.

Device Description

Not Found

AI/ML Overview

I am sorry. This document is a 510(k) clearance letter from the FDA to Te Me Na S.A.R.L. for their Model C20900-03 Polymedic Epidural Catheter. It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

The document does not contain information about any AI/ML device, clinical study, acceptance criteria for an AI/ML device, or device performance metrics. Therefore, I cannot provide the requested information based on this text.

§ 868.5120 Anesthesia conduction catheter.

(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).