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510(k) Data Aggregation
K Number
K061240Device Name
SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES
Manufacturer
LUCENT MEDICAL SYSTEMS
Date Cleared
2006-06-02
(30 days)
Product Code
LJS
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
LUCENT MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sherlock™ Tip Location System (TLS) Detector quickly locates and confirms the position of specially designed, magnet-tipped Peripherally.Inserted Central Catheters (PICCs) and Central Venous Catheters (CVCs) during initial placement. This device may be used by appropriate caregivers in hospitals, long-term care facilities or home-care settings. The Sherlock™ Tip Location System (TLS) Detector provides rapid feedback to the caregiver, but was not designed to replace conventional methods of placement verification. Users are urged to confirm correct placement according to their established institutional protocol and clinical judgment.
Device Description
The Sherlock™ Tip Location System (TLS) Detector is a battery or line powered hand held device which detects the location of a magnet-tipped catheter stylet. A battery charger is also provided. The Sherlock™ Tip Location System (TLS) Detector uses only passive field sensors, and does not emit energy of any sort into the patient. The Sherlock™ Tip Location System (TLS) Detector is designed (and labeled) to be used only with a compatible PICC or CVC intravascular catheter stylet which contains one or more small, specially oriented magnets encapsulated at the distal end. It provides rapid feedback to a caregiver about the location and orientation of these magnet-tipped devices during initial placement.
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K Number
K000997Device Name
ZORTRAN DETECTOR
Manufacturer
LUCENT MEDICAL SYSTEMS
Date Cleared
2000-09-07
(163 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
LUCENT MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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