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510(k) Data Aggregation
K Number
K161102Device Name
Nanostim Introducer Kit
Manufacturer
ST JUDE MEDICAL, INC.
Date Cleared
2016-05-19
(30 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
ST JUDE MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.
Device Description
The St Jude Medical Nanostim Introducer Kit is designed to perform as a guiding sheath for introduction of diagnostic and interventional devices. The Nanostim™M Introducer Kit is comprised of an introducer sheath and a dilator. The Introducer Kit is compatible with 0.035" and 0.038" guidewires and is available in one size (18F) and two lengths (30cm and 50cm).
The introducer is fitted with a hemostasis valve to minimize air introduction during insertion and/or exchange, and a sideport with a three-way stopcock. The introducer features a radiopaque tip marker incorporated within the sheath material to identify the location of the distal tip of the sheath. Design modifications were made to the length and packaging of the current device. The changes made to the Nanostim Introducer Kit do not affect the intended use of the device or alter the fundamental scientific technology of the device.
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K Number
K160716Device Name
The Nanostim Introducer Kit
Manufacturer
St Jude Medical, Inc
Date Cleared
2016-04-14
(30 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
St Jude Medical, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.
Device Description
The St Jude Medical Nanostim Introducer Kit is designed to perform as a quiding sheath for introduction of diagnostic and interventional devices. The Nanostim™ Introducer Kit is comprised of an introducer sheath and a dilator. The Introducer Kit is compatible with 0.035" and 0.038" guidewires and is available in 18F and one length of 30 cm.
The introducer is fitted with a hemostasis valve to minimize air introduction during insertion and/or exchange, and a sideport with a three-way stopcock. The introducer features a radiopaque tip marker incorporated within the sheath material to identify the location of the distal tip of the sheath. Design modifications were made to the current design to improve the manufacturability and to increase the product shelf life. The changes made to the Nanostim Introducer Kit do not affect the intended use of the device or alter the fundamental scientific technology of the device.
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