LogoFDA 510(k) Search
K Number
K012392
Device Name
DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260
Manufacturer
PACE MEDICAL
Date Cleared
2001-09-04

(39 days)

Product Code
DSA
Regulation Number
870.2900
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For use in conjunction with a Model 4815 Adapter for connecting a non-sterile pacing (system) analyzer to a patient's cardiac pacing lead system, allowing the analyzer to be located at some distance from the patient, outside of the sterile field.

Device Description

Model 4255 or Model 4260 Disposable Extension Cables

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for "Model 4255 or Model 4260 Disposable Extension Cables." It primarily states that the device is substantially equivalent to a predicate device and can be marketed. It does not include details about acceptance criteria, study designs, sample sizes, ground truth establishment, or specific performance metrics.

§ 870.2900 Patient transducer and electrode cable (including connector).

(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).