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510(k) Data Aggregation
K Number
K243938Device Name
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire
Manufacturer
Scientia Vascular Inc
Date Cleared
2025-04-01
(102 days)
Product Code
MOF
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Scientia Vascular Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aristotle 14 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
The Aristotle 18 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
The Aristotle 24 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
The Zoom Wire 14 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
The Aristotle Colossus Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
Device Description
The Scientia Vascular's Aristotle 14, Aristotle 18, Aristotle 24, Zoom Wire 14, and Aristotle Colossus Guidewires ("the guidewires") are steerable guidewires with a shapeable tip to aid in accessing the neuro and peripheral vasculatures. The guidewires are supplied sterile, for single use only.
The distal portion of each guidewire's tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. All guidewires have a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels.
The guidewires are provided with an accessory kit consisting of an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve), a torque device (to attach to the proximal portion of the guidewire to facilitate gripping and manipulation of the guidewire during use), and a shaping mandrel (to aid in shaping the flexible tip of the guidewire). These accessory devices are included to facilitate use of the guidewires and are not intended to contact the patient's body.
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K Number
K242301Device Name
Socrates 38 Catheter
Manufacturer
Scientia Vascular Inc
Date Cleared
2024-12-04
(124 days)
Product Code
QJP, DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Scientia Vascular Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Socrates™ 38 Catheter is indicated for use in facilitating the insertion and guidance of an appropriate microcatheter or diagnostic agents into a selected blood vessel in the peripheral or neuro vasculature. The Socrates™ 38 Catheter is not intended for use in the coronary vasculature.
Device Description
Scientia Vascular's Socrates™ 38 Catheter is a single lumen, variable stiffness, open-ended catheter designed to track through a guide catheter using a steerable guidewire and microcatheter. The catheter shaft design includes nitinol, polymers of varying durometer, and an internal lubricious liner. To reduce friction during manipulation, a hydrophilic coating is applied to the distal exterior section of the catheter shaft. A single radiopaque tip marker provides visualization under fluoroscopy. The proximal end of the catheter includes a clear hub with luer lock and a stainless-steel strain relief. The catheter is supplied sterile, for single use only and is packaged with a rotating hemostasis valve (RHV).
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K Number
K223913Device Name
Socrates Aspiration System
Manufacturer
Scientia Vascular Inc
Date Cleared
2023-09-20
(265 days)
Product Code
NRY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Scientia Vascular Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As part of the Socrates Aspiration System, the Socrates 38 Aspiration Catheter with a compatible suction pump is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral -M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
As part of the Socrates Aspiration System, the Socrates Aspiration Tubing is indicated to connect the Socrates 38 Aspiration Catheter to a compatible suction pump.
Device Description
The Scientia Vascular Socrates Aspiration System is composed of two components: the Socrates 38 Aspiration Catheter, designed to aid in accessing vasculature, and the Socrates Aspiration Tubing, designed to connect the aspiration catheter to a compatible suction pump and control flow between them. When used with a compatible vacuum pump, these components facilitate the aspiration and removal of thrombus from the neurovasculature. Both components are supplied sterile for single use only.
The Socrates 38 Aspiration Catheter is a single lumen, variable stiffness catheter designed to be advanced over a steerable guidewire. The catheter shaft design includes nitinol, polymers of varying durometer, and an internal lubricious liner. To reduce friction during manipulation, a hydrophilic coating is applied to the distal exterior section of the catheter shaft. A single radiopaque tip marker provides visualization under fluoroscopy. The proximal end of the catheter includes a clear hub with Luer lock and a stainless-steel strain relief. The catheter is supplied sterile, for single use only and is packaged with a rotating hemostasis valve (RHV).
The Socrates Aspiration Tubing is designed to connect the Socrates 38 Aspiration Catheter to a compatible vacuum pump and control flow between them. The aspiration tubing consists of tubing attached to a suction connector on one end and a male Luer lock on the other with an intermediate on/off fluid flow control device and is supplied sterile and for single use only.
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K Number
K223560Device Name
Plato 17 Microcatheter
Manufacturer
Scientia Vascular Inc
Date Cleared
2023-08-21
(266 days)
Product Code
QJP, DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Scientia Vascular Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Plato 17 Microcatheter is intended for the introduction of therapeutic devices, infusion of diagnostic agents, such as contrast media, and delivery of embolization materials to the peripheral and neuro vasculature systems. The Plato 17 Microcatheter is not intended for use in the coronary vasculature.
Device Description
Scientia Vascular's Plato® 17 Microcatheter is a single lumen, open-ended catheter designed to be flexible and axially stable, to aid the physician in the accessing of the distal neuro and peripheral vasculature. The Plato® 17 Microcatheter is supplied sterile and is for single use only. The Plato® 17 Microcatheter is supplied in various tip configurations, including straight and pre-shaped (45° and 90°). The microcatheter shaft design includes nitinol, polymers of varying durometer, and an internal liner providing lubricity for therapeutic device, diagnostic agent, and embolization material delivery. The distal exterior section of the catheter shaft is hydrophilic coated to reduce friction during manipulation in vessels. The microcatheter includes two radiopaque tip markers to facilitate fluoroscopic visualization and a clear hub with luer lock and a strain relief.
The microcatheter is provided with a steam shaping mandrel, peel-away introducer, and a ruler. The shaping mandrel, peel-away introducer, and ruler are accessories included to facilitate use of the microcatheter and are not intended to contact the patient's body.
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K Number
K222437Device Name
Aristotle Colossus Guidewire
Manufacturer
Scientia Vascular Inc
Date Cleared
2023-01-26
(167 days)
Product Code
MOF, DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Scientia Vascular Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aristotle Colossus Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
Device Description
Scientia Vascular's Aristotle Colossus Guidewire is a modification of Scientia Vascular's Aristotle 24 Guidewire. It is a 0.035" diameter, steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a single stiffness profile (standard) and is available in a range of lengths from 150 cm to 300 cm. The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in tortuous vessels.
The guidewire is provided with a shaping mandrel, an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a rotating hemostasis valve (RHV)), and a torque device (to attach to the proximal portion of the guidewire to facilitate gripping and manipulation of the guidewire during use). The shaping mandrel, introducer, and torque device accessories are included to facilitate use of the guidewire and are not intended to contact the patient's body.
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