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510(k) Data Aggregation
K Number
K080621Device Name
FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01
Manufacturer
EUROPEAN CUSTOM MANUFACTURING BV
Date Cleared
2008-04-29
(55 days)
Product Code
DSA
Regulation Number
870.2900Why did this record match?
Applicant Name (Manufacturer) :
EUROPEAN CUSTOM MANUFACTURING BV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fastlock pacing wire extension cable with connectors is indicated for use as an electrical extension cable used to transmit signal from, or power or excitation signal to patient-connected electrodes.
Device Description
The Fastlock pacing wire extension cable device provides simple connection between an external pacemaker and pacing wires that are attached to a patient body, in order to transmit low voltage electrical signals between the devices and sensors. The Fastlock product is limited by the Indications for Use of the connected external pacemaker.
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K Number
K033858Device Name
TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE
Manufacturer
EUROPEAN CUSTOM MANUFACTURING BV
Date Cleared
2004-07-12
(214 days)
Product Code
LDF
Regulation Number
870.3680Why did this record match?
Applicant Name (Manufacturer) :
EUROPEAN CUSTOM MANUFACTURING BV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Temporary Bipolar Myocardial Pacing Wire functions as a temporary implant for the transmission of electrical heart pacing signals. The heart wire is placed following cardiac surgery to be in direct contact with the native myocardium while the natural heart is surgically exposed. The wire may be used on either the atrium or ventricle.
Device Description
Temporary Bipolar Myocardial Pacing Wire
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