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Found 10 results
510(k) Data Aggregation
K Number
K152560Device Name
Bard Snare Retrieval Kit
Manufacturer
NEOMETRICS, INC
Date Cleared
2015-10-23
(44 days)
Product Code
MMX
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
NEOMETRICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bard® Snare Retrieval Kit is intended for use to percutaneously remove all Bard optional vena cava filters with a retrieval hook.
Device Description
The Bard® Snare Retrieval Kit is intended to percutaneously remove Bard filters from the vena cava.
The Bard® Snare Retrieval Kit consists of a Nitinol Snare with 6 French Snare Catheter Assembly and a 11 French O.D Retrieval Sheath with 9 French Dilator Assembly.
The nitinol snare has a 20 mm diameter (fully expanded) radiopaque loop and comes preloaded in the snare catheter. The snare catheter, retrieval sheath, and access sheath have radiopaque marker bands at the distal ends for enhanced fluoroscopic visualization.
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K Number
K150225Device Name
NovaGold High Performance Guidewire
Manufacturer
NEOMETRICS, INC.
Date Cleared
2015-03-16
(42 days)
Product Code
OCY
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
NEOMETRICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NovaGold Guidewire is intended for use in selective cannulation of the billary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic devices during endoscopic procedures.
Device Description
The NovaGold Guidewire is constructed from a steerable, metallic core with a PTFE polymer coating over the shaft. A hydrophilic coating is applied over the distal portion of the device. The guidewire has a radiopaque, floppy tip.
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K Number
K143135Device Name
Spring Coil Guidewire
Manufacturer
NeoMetrics, Inc.
Date Cleared
2015-02-20
(112 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
NeoMetrics, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To facilitate the placement of devices during diagnostic or interventional procedures.
Device Description
NeoMetrics guidewires are constructed using stainless steel and nickel titanium alloys. Configurations include a single tip or dual tip, retracted core or fixed core, and straight or J-tipped. The guidewire is packaged in a spiral hoop fitted with a "J"-Straightener, where applicable to aid in insertion of the guidewire into the puncture needle.
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K Number
K133076Device Name
NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
Manufacturer
NEOMETRICS, INC.
Date Cleared
2014-02-20
(143 days)
Product Code
OCY
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
NEOMETRICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
Device Description
The NovaGold Guidewire is constructed from a steerable, metallic core with a PTFE polymer coating over the shaft. A hydrophilic coating is applied over the distal portion of the device. The guidewire has a radiopaque, floppy tip.
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K Number
K123439Device Name
NEO ERCP GUIDEWIRE
Manufacturer
NEOMETRICS, INC.
Date Cleared
2013-01-03
(56 days)
Product Code
OCY
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
NEOMETRICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Neo ERCP Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
Device Description
The Neo ERCP Guidewire is constructed of a core wire of nickel titanium based alloy, a proximal polymer jacket and a radiopaque distal tip. It also features a hydrophilic coating and either straight or angled distal tip configurations. The distal end of the guidewire has a radiopaque distal tip (10cm). The wire family has two models, the Phantom refers to .025" OD models and the Palomino refers to .035" OD models. Both the Phantom and Palomino come in 260cm and 480cm lengths.
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K Number
K070150Device Name
VASCUPUNCTURE PICC GUIDEWIRE
Manufacturer
NEOMETRICS, INC.
Date Cleared
2007-02-15
(30 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
NEOMETRICS, 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. The device is 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 or without lubricious coatings. Devices are available in diameters of 0.014 to 0.018 inches and in lengths ranging from 40 to 145 cm. with a variety of coil material options available.
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K Number
K001455Device Name
ACCUWELL TSH, MODEL KAW-TSH-960
Manufacturer
NEOMETRICS, INC.
Date Cleared
2000-11-02
(177 days)
Product Code
JLW
Regulation Number
862.1690Why did this record match?
Applicant Name (Manufacturer) :
NEOMETRICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991498Device Name
ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL
Manufacturer
NEOMETRICS, INC.
Date Cleared
1999-06-16
(48 days)
Product Code
JIA
Regulation Number
862.1310Why did this record match?
Applicant Name (Manufacturer) :
NEOMETRICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Neometrics' ACCUWELL™ Total Galactose kits are intended to be used for the quantitative measurment of Total Galactose in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen newborns for galactosemia.
Device Description
Not Found
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K Number
K974047Device Name
ACCUWELL PHENYLALANINE ASSAY
Manufacturer
NEOMETRICS, INC.
Date Cleared
1997-12-05
(42 days)
Product Code
JNB
Regulation Number
862.1555Why did this record match?
Applicant Name (Manufacturer) :
NEOMETRICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Neometrics' ACCUWELL™ Phenylalanine kits are intended to be used for the quantitative measurement of phenylalanine in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen for phenylketonuria disease.
Device Description
Not Found
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K Number
K972974Device Name
ACCUWELL T4-EIA
Manufacturer
NEOMETRICS, INC.
Date Cleared
1997-10-06
(56 days)
Product Code
KLI
Regulation Number
862.1700Why did this record match?
Applicant Name (Manufacturer) :
NEOMETRICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Neometrics' Accuwell™ T4 EIA kits are intended to be used for the quantitative measurement of Thyroxine in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen newboros for congenital hypothyroidism.
Device Description
Not Found
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