LogoFDA 510(k) Search
K Number
K951927
Device Name
COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER)
Manufacturer
CSEN LTD.
Date Cleared
1997-05-30

(767 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

Not Found

Device Description

Combined End Multilateral Holes (CEMLH) Epidural Catheter

AI/ML Overview

This document does not contain the detailed technical information required to describe the acceptance criteria and the study that proves the device meets those criteria. The provided text is a letter from the FDA regarding a 510(k) premarket notification for an epidural catheter, stating that the device has been found substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information, as the input document focuses on regulatory approval rather than a description of a scientific study characterizing device performance.

§ 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).