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Found 7 results
510(k) Data Aggregation
K Number
K101729Device Name
NEOWIRE PTA/PTCA GUIDEWIRE
Manufacturer
NEO METRICS, INC.
Date Cleared
2010-09-23
(94 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
NEO METRICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeoWire Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices within the coronary and/or peripheral vasculature. Models with Stiff tips (> 9g) are intended for peripheral use only. Models with Floppy, Soft, and Medium tips (≤ 9g) are intended for peripheral or coronary use. The guidewire is not intended for use in the cerebral vasculature.
Device Description
NeoWire is a steerable guidewire constructed of a nitinol alloy core with a coiled segment on the distal end. The core wire is either PTFE coated or uncoated and the wire may also contain silicone or hydrophilic lubricious coatings. This distal end of the wire can be shapeable and is radiopaque.
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K Number
K043398Device Name
MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE
Manufacturer
NEO METRICS, INC.
Date Cleared
2005-03-01
(81 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
NEO METRICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. VascuPuncture Guidewires are not indicated for use in the coronary or cerebral vasculature.
Device Description
The VascuPuncture™ PICC Guidewires are guidewires constructed of stainless steel and nickel titanium alloy with a lubricious coating. Devices are available in diameters of 0.014 to 0.018 inches and in lengths ranging from 45 to 135 cm.
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K Number
K040786Device Name
VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING
Manufacturer
NEO METRICS, INC.
Date Cleared
2004-04-19
(21 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
NEO METRICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessies using the Seldinger technique. VascuPuncture Guidewires are not indicated for use in the coronary or cerebral vasculature.
Device Description
The VascuPuncture™ PICC Guidewires are guidewires constructed of stainless steel and nickel titanium alloy with a lubricious coating. Devices are available in diameters of 0.014 and 0.018 inches and in lengths ranging from 45 to 145 cm.
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K Number
K033321Device Name
SELECTIVA SB GUIDEWIRE
Manufacturer
NEO METRICS, INC.
Date Cleared
2003-11-05
(21 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
NEO METRICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeoMetrics Selectiva SB Guidewire is intended to facilitate the placement of devices for diagnostic and interventional procedures.
NOTE: These guidewires are not intended for PTCA use.
Device Description
The Selectiva SB Guidewires are constructed of a nickel-titanium alloy with a PTFE polymer jacket. Devices are available in a diameter of 0.035 inches and in lengths ranging from 40 to 300 cm.
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K Number
K031652Device Name
VASCUPUNCTURE PICC GUIDEWIRE
Manufacturer
NEO METRICS, INC.
Date Cleared
2003-09-30
(125 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
NEO METRICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VascuPuncture PICC Guidewire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. VascuPuncture Guidewires are not intended for use in the coronary or cerebral vasculature.
Device Description
The VascuPuncture PICC Guidewires are guidewires constructed of stainless steel and nickel titanium alloy with a lubricious coating. Devices are available in diameters of 0.014 and 0.018 inches and in lengths ranging from 45 to 145 cm.
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K Number
K012861Device Name
VASCUPUNCTURE ACCESS WIRE
Manufacturer
NEO METRICS, INC.
Date Cleared
2002-02-05
(165 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
NEO METRICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THE NEOMETRICS VASCUPUNCTURE ACCESS WIRE IS IN DICATED FOR PERCUTANEOUS VASCULAR ENTRY USING THE SELDINGER TECHNIQUE,
Device Description
This guidewire has a 0.0175" diameter and is available in lengths of 45-120 cm. It features gradual diameter changes in the distal section to facilitate vascular insertion and compatibility with various introducers and catheters. A variety of distal tapers impart different tip flexibilities.
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K Number
K013024Device Name
SELECTIVA GUIDEWIRE
Manufacturer
NEO METRICS, INC.
Date Cleared
2001-12-04
(88 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
NEO METRICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To facilitate the placement of devices for diagnostic and interventional procedures. NOTE: These guidewires are not intended for PTCA use.
Device Description
The Selective™ Guidewire is used to facilitate the placement of devices for diagnostic and interventional procedures. The shaft of the device is constructed of PES (polyethersulfone) coated Nitinol or stainless steel with a tapered distal end secured to a platinum or stainless steel helical coil. A selection of distal tapers imparts different tip flexibilities. The guidewire is coated with silicone fluid to improve lubricity. The Selectiva™ Guidewire will be offered in diameters of 0.018" - 0.035" and lengths of 60 cm - 260 cm. It will be supplied sterile, intended for one-time use.
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