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Found 4 results
510(k) Data Aggregation
K Number
K053310Device Name
VASCON ROAMER MICROCATHETER
Manufacturer
VASCON LLC
Date Cleared
2008-07-03
(948 days)
Product Code
KRA
Regulation Number
870.1210Why did this record match?
Applicant Name (Manufacturer) :
VASCON LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VasCon Roamer Microcatheters are indicated for the selective infusion of various diagnostic, therapeutic, and embolic agents into the peripheral, coronary, and neurovasculature.
Device Description
The VasCon Roamer Microcatheters are single lumen catheters, incorporating a Pebax body reinforced with stainless steel and platinum wire, a PTFE lubricious inner lumen, and a soft radiopaque tip to reduce potential vessel injury. They are available in French sizes of 2.3/1.9, 2.8/2.3, 3.0/2.8, 2.4/2.0, and 2.8/2.7 and in lengths of 105 cm, 135 cm, and 150 cm. The inside diameters are 0.017, 0.019, 0.021, and 0.027 inches. They have a hydrophilic coating to provide lubricity during use.
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K Number
K052004Device Name
VASCON NEUROPATH GUIDING CATHETER
Manufacturer
VASCON LLC
Date Cleared
2006-01-19
(178 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
VASCON LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VasCon NeuroPath™ Guiding Catheter is intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices.
Device Description
The VasCon NeuroPath™ Guiding Catheter is a single lumen catheter, incorporating a PEBAX® body reinforced with a stainless steel wire braid. The intermediate segment is also PEBAX® with a stainless steel coil to reduce kinking and to promote improved torque response. The tip is composed of radiopaque 35D PEBAX® to reduce potential vessel injury. They are available in 5Fr and 6Fr, 90 and 100 cm in length, and in a variety of shapes. The technological characteristics are equivalent to the predicate devices.
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K Number
K043387Device Name
VASCON POLARIS GUIDING CATHETER
Manufacturer
VASCON LLC
Date Cleared
2005-02-16
(69 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
VASCON LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.
Device Description
The VasCon Polaris™ Guiding Catheters are single lumen catheters, incorporating a nylon body reinforced with a stainless steel wire braid, a PTFE lubricious inner lumen, and a soft radiopaque tip to reduce potential vessel injury. They are available in 5Fr, 6Fr, 7Fr, and 8Fr, 100 cm in length, and in a variety of shapes. The technological characteristics are equivalent to the predicate device.
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K Number
K033633Device Name
VASCON POLARIS GUIDING CATHETER
Manufacturer
VASCON LLC
Date Cleared
2004-02-18
(91 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
VASCON LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.
Device Description
The VasCon Polaris™ Guiding Catheters are single lumen catheters, incorporating a nylon body reinforced with a stainless steel wire braid, a PTFE lubricious inner lumen, and a soft radiopaque tip to reduce potential vessel injury. They are available in 5Fr, 6Fr, 7Fr, and 8Fr, 100 cm in length, and in a variety of shapes. The technological characteristics are equivalent to the predicate device.
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