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510(k) Data Aggregation
K Number
K970690Device Name
LOCKING STYLET 2
Manufacturer
COOK PACEMAKER CORP.
Date Cleared
1997-05-20
(84 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
COOK PACEMAKER CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Locking Stylet 2 is intended for use during the percutaneous removal of cardiac leads, indwelling catheters and other foreign objects having a central lumen.
Device Description
The Locking Stylet 2 is used during the percutaneous removal of cardiac leads, indwelling catheters and other foreign objects having a central lumen. The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the Locking Stylet 2 is provided by their established history of use in medical product manufacturing by COOK Vascular™ Incorporated.
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K Number
K961992Device Name
NEEDLE'S EYE SNARE
Manufacturer
COOK PACEMAKER CORP.
Date Cleared
1996-12-27
(220 days)
Product Code
DXE
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
COOK PACEMAKER CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Needle's Eye Snare is intended for use in the percutaneous removal of indwelling catheters, cardiac leads, fragments and foreign objects.
Device Description
The Needle's Eye Snare is intended for use in the percutaneous removal of indwelling catheters, cardiac leads, fragments and foreign objects. The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the Needle's Eye Snare is provided by their established history of use in medical devices manufactured by the Cook Pacemaker Corporation.
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