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Found 9 results
510(k) Data Aggregation
K Number
K070502Device Name
RADIUS SNARE
Manufacturer
RADIUS MEDICAL TECHNOLOGIES, INC.
Date Cleared
2007-10-04
(225 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
RADIUS MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K071457Device Name
MODIFICATION TO RADIUS SNARE
Manufacturer
RADIUS MEDICAL TECHNOLOGIES, INC.
Date Cleared
2007-09-25
(123 days)
Product Code
MMX
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
RADIUS MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Radius Snare is intended for use in the cardiovascular system and hollow viscous to retrieve and/or manipulate objects using minimally invasive surgical procedures. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the cardiovascular system.
Device Description
The Radius Snare is composed of two primary parts: a stainless steel outer sheath tube and a stainless steel core wire with a loop snare attached to the distal end. The outer sheath acts as a catheter through which the core wire, with snare, slides. The Radius Snare has loop sizes which range from 5 - 35 millimeters. The over-all length of the device is 150 centimeters. The Radius Snare is packaged in a mylat/Tyvek pouch and ETO sterilized to SAL 10°.
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K Number
K032899Device Name
RADIUS COUGAR WIRE
Manufacturer
RADIUS MEDICAL TECHNOLOGIES, INC.
Date Cleared
2003-10-17
(30 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
RADIUS MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Modified Radius Cougar Wire is intended to facilitate the placement of balloon dilitation catheters during PTCA and/or PTA. The Modified Radius Cougar Wires are compatible with all currently approved and marketed PTCA balloon catheters which are labeled for use with an 014 guidewire.
Device Description
The Modified Radius Cougar Wire is constructed from a composite stainless steel and Nitinol core to which a coil is attached to the tapered distal section. The proximal section of the wire is coated with PTFE, and the distal coil portion of the wire is hydrophilic coated. The device is packaged in a protective hoop sealed into a Tyvek/mylar pouch, and is sterilized using ETO gas.
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K Number
K032129Device Name
RADIUS 018 COUGAR WIRE
Manufacturer
RADIUS MEDICAL TECHNOLOGIES, INC.
Date Cleared
2003-07-17
(7 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
RADIUS MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Radius .018 Cougar Wire is intended to facilitate the placement of balloon dilitation catheters during PTCA and/or PTA. The Radius .018 Cougar Wires are compatible with all currently approved and marketed PTCA/PTA balloon catheters which are labeled for use with an .018 guidewire.
Device Description
The Radius .018 Cougar Wire is constructed from a composite stainless steel and Nitinol core to which a coil is attached to the tapered distal section. The proximal section of the wire is coated with PTFE, and the distal coil portion of the wire is hydrophilic coated. The device is packaged in a protective hoop sealed into a Tyvek/mylar pouch, and is sterilized using ETO gas.
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K Number
K022201Device Name
RADIUS MICRO SNARE
Manufacturer
RADIUS MEDICAL TECHNOLOGIES, INC.
Date Cleared
2003-02-03
(213 days)
Product Code
MMX
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
RADIUS MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Radius Micro Snare is intended for use to retrieve and/or manipulate objects in the distal peripheral vessels of the cardiovascular system and hollow viscus. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the peripheral and cardiovascular system.
Device Description
The Radius Micro Snare is composed of two primary parts: an outer sheath tube and a core wire with a snare attached to the distal end. The outer sheath acts as a catheter through which the core wire, with snare, slides. The outer sheath is a stainless steel tube joined to a polyimide tube. The stainless steel and polyimide tubes are covered with PTFE. The stainless steel core is a solid .008" diameter stainless steel core that is a smaller version of the solid core wire in the FDA cleared Radius PTCA Guidewire and the FDA cleared Radius Snare. A stainless steel loop is soldered to the distal end of the core. The Radius Micro Snare has loop sizes, which range from 2 - 7 millimeters. The over-all length of the device is 190 centimeters. A molded ABS operating handle is included on the proximal end of the Micro Snare to aid in advancing and retracting the outer sheath over the snare loop. The Radius Micro Snare will be packaged in a Mylar/Tyvek pouch and ETO sterilized to SAL 10-6.
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K Number
K021441Device Name
RADIUS SNARE
Manufacturer
RADIUS MEDICAL TECHNOLOGIES, INC.
Date Cleared
2002-06-14
(39 days)
Product Code
MMX
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
RADIUS MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Radius Snare is intended for use in the cardiovascular system and hollow viscous to retrieve and/or manipulate objects using minimally invasive surgical procedures. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the cardiovascular system.
Device Description
The Radius Snare is composed of two primary parts: an outer sheath tube and a core wire with a snare attached to the distal end. The outer sheath acts as a catheter through which the core wire, with snare, slides. The outer sheath is a stainless steel coil with a PTFE overjacket. The stainless steel core is the same solid .0135" diameter stainless steel core wire in the FDA cleared Radius PTCA Guidewire. A stainless steel loop is soldered to the distal end of the core wire. The Radius Snare has loop sizes which range from 5 - 35 millimeters. The over-all length of the device is 150 centimeters. The Radius Snare will be packaged in a mylar/Tyvek pouch and ETO sterilized to SAL 10-2.
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K Number
K011759Device Name
RADIUS NEXT GENERATION GUIDEWIRE
Manufacturer
RADIUS MEDICAL TECHNOLOGIES, INC.
Date Cleared
2001-08-23
(78 days)
Product Code
OCY, GCA
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
RADIUS MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Next Generation Guidewire is designed to be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. The guidewire is indicated for selective cannulation of the biliary ducts, including but not limited to the common bile duct, cystic, pancreatic, and right and left hepatic ducts.
Device Description
Radius Medical Technologies, Inc. has developed a line of Endoscopic guidewires ranging in sizes of 0.025" to 0.035" diameter and lengths of 260 cm to 450 cm (in standard and stiff body types). The wires will be offered with a 5 cm radiopaque distal tip (angled and straight). The wires are constructed of a solid nitinol core wire, which tapers at its distal end. A shrink jacket surrounds the core over the entire length except the distal most 5 cm. A radiopaque tube covers the distal 5 cm. Single striped bands of ink are placed circumferentially onto the jacket and spaced in 1 cm intervals beginning at the 6 cm location and continuing to the 40 cm location from the distal tip. Multiple ink bands are used to delineate the 10, 15, and 20 cm locations. A coating is applied over the tip portion of the guidewire.
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K Number
K011287Device Name
RADIUS COUGAR WIRE
Manufacturer
RADIUS MEDICAL TECHNOLOGIES, INC.
Date Cleared
2001-05-25
(28 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
RADIUS MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K970466Device Name
RADIUS PTCA GUIDEWIRE
Manufacturer
RADIUS MEDICAL TECHNOLOGIES, INC.
Date Cleared
1997-05-20
(102 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
RADIUS MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Radius PTCA Guidewire is intended to facilitate the placement of balloon dilitation catheters during PTCA and/or PTA. Radius PTCA Guidewires are compatible with all currently approved and marketed PTCA balloon catheters which are labeled for use with an .014 guidewire.
Device Description
The Radius PTCA Guidewire is constructed from a solid stainless steel core to which a coil is attached to the tapered distal section. The proximal section of the wire is coated with PTFE, and the distal coil portion of the wire is silicone coated. The device is packaged in a protective hoop sealed into a Tyvek/mylar pouch, and is sterilized using ETO gas.
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