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Found 10 results
510(k) Data Aggregation
K Number
K233729Device Name
Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58
Manufacturer
Vascular Solutions LLC
Date Cleared
2024-05-31
(192 days)
Product Code
LOX
Regulation Number
870.5100Why did this record match?
Applicant Name (Manufacturer) :
Vascular Solutions LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ringer Perfusion Balloon Catheter is indicated for balloon dilatation of coronary artery or coronary bypass graft stenoses where the physician desires distal blood perfusion during balloon inflation for the purpose of improving myocardial perfusion.
Device Description
The Ringer perfusion balloon catheter is a rapid exchange catheter with a spiral-shaped inflatable balloon on the distal end and a wire lumen for delivery over a ≤ 0.014" guidewire. The inflated spiral balloon approximates a hollow cylinder. Radiopaque markers at the proximal and distal end of the balloon facilitate visualization and intravascular placement of the catheter prior to inflation. The catheter shaft has positioning marks located at 95cm (single mark) and 105cm (double mark) from the distal tip. The Ringer perfusion balloon catheter has been sterilized with ethylene oxide.
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K Number
K230637Device Name
Wattson temporary pacing guidewire (2250)
Manufacturer
Vascular Solutions LLC
Date Cleared
2023-05-05
(59 days)
Product Code
DQX, DOX, LDF
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Vascular Solutions LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wattson temporary pacing guidewire is intended to introduce and position catheters and other interventional devices within the chambers of the heart, including those used within transcatheter aortic valve replacement (TAVR) procedures and balloon aortic valvuloplasty (BAV), while transmitting an electrical signal from an external pulse generator to the heart. The temporary pacing guidewire is not intended to remain in place following the clinical procedure.
Device Description
The Wattson temporary pacing guidewire is a dual-purpose 0.035" guidewire designed for the delivery of devices and for temporary pacing of the heart. The distal end of the device has an atraumatic pigtail shape. The shaft of the device has a hydrophilic coating. Pacing is achieved through a bipolar electrode configuration integrated in the guidewire. The electrodes terminate in a single positive electrode at the distal tip of the device and three discrete negative electrodes located proximal to the tip within the pigtail section. The entire device is visible using standard fluoroscopic methods. The device is packaged with a proprietary adapter that locks on to the proximal end of the guidewire and converts it to discrete positive and negative terminal pins. The terminal pins of the adapter are compatible with standard external pulse generators. Unshrouded adaptor pins are provided to ensure compatibility with all connecter cable terminals. The Wattson temporary pacing guidewire is sterilized with ethylene oxide.
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K Number
K220647Device Name
GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)
Manufacturer
Vascular Solutions LLC
Date Cleared
2022-08-18
(164 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Vascular Solutions LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, and to assist in crossing de novo coronary chronic total occlusions (CTO).
Device Description
The GuideLiner Coast catheter is a rapid-exchange guide extension catheter designed for use in the coronary and peripheral vasculature. It is available in four sizes - 5.5F, 6F, 7F, and 8F. All sizes of the GuideLiner Coast catheter have a 150 cm working length, consisting of a 125 cm long stainless steel pushwire shaft followed distally by a 25 cm long full-round, hydrophilic coated guide extension segment. The distal 17 cm of the 125 cm pushwire shaft is covered with a semicircular shaped polymer that meets the proximal end of the full-round guide extension segment.
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K Number
K221470Device Name
Langston dual lumen catheter
Manufacturer
Vascular Solutions LLC
Date Cleared
2022-06-17
(28 days)
Product Code
DQO
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
Vascular Solutions LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Each Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.
Device Description
The Langston dual lumen catheters have two lumens, both with distal sideholes, to allow simultaneous pressure measurements from two sites. The high-pressure inner lumen, which extends the entire length of the catheter, can be used for pressurement and rapid delivery of contrast medium. The outer lumen ends proximal to the distal end of the catheter and is used for pressure measurement only. A side port fitted with an extension tube and a stopcock assembly is used for fluid flow and pressure measurement within the outer lumen. The Langston dual lumen catheter will accommodate a standard ≤ 0.038" diameter guidewire and is supplied with a single use pigtail straightener. The Langston dual lumen catheter is sterilized with ethylene oxide.
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K Number
K212167Device Name
R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire
Manufacturer
Vascular Solutions LLC
Date Cleared
2022-02-09
(212 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Vascular Solutions LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The R350 guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, including use in crossing de novo coronary chronic total occlusions (CTO).
The Spectre guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature. including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).
The Raider guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).
The Bandit guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature. including use in crossing de novo coronary chronic total occlusions (CTO).
The Warrior guidewire is intended for use in percutaneous procedures to introduce and position cathers and other interventional devices within the coronary and peripheral vasculature, including use in crossing de novo coronary chronic total occlusions (CTO).
Device Description
R350 Guidewire:
The R350 guidewire is an extended length (350 cm) guidewire with a 0.013″ maximum outer diameter (OD) (0.012" nominal OD). It is composed of a nitinol alloy mandrel with a straight, radiopaque 5 cm gold-coated tungsten coil distal tip. The proximal 150 cm of the R350 guidewire has a polytetrafluoroethylene (PTFE) coating, while the distal 200 cm has a hydrophilic coating.
Spectre Guidewire:
The Spectre guidewire is a nitinol and stainless-steel guidewire with a 0.014″ diameter and straight shapeable tip. It is available in 200 cm and 300 cm lengths. The distal 25 cm of the guidewire has a spring coil with a 3 cm platinum coil on the distal tip that is visible under fluoroscopic methods. The distal 42 cm of the guidewire has a hydrophilic coating and the proximal portion has a PTFE coating.
Raider Guidewire:
The Raider guidewire is a stainless-steel core guidewire with a maximum outer diameter of 0.014″ and a straight, shapeable tip. It is available in 200 cm and 300 cm lengths. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating. The 200 cm model has a modified proximal end to allow for guidewire extension.
Warrior Guidewire:
The Warrior guidewire is a stainless-steel core guidewire with a 0.014" diameter that tapers to a 0.009" diameter distal tip. It is available in 200 cm and 300 cm lengths. The distal 20 cm of the guidewire has a spring coil, of which the distal 2.5 cm is visible under fluoroscopic methods. The guidewire has a straight shapeable tip with a tip load of 14 grams. The distal portion of the guidewire has a hydrophilic coating and the proximal portion has a PTFE coating. The 200 cm model has a modified proximal end to allow for guidewire extension.
Bandit Guidewire:
The Bandit guidewire is a 0.014″ diameter stainless steel core guidewire with a 0.008″ diameter tapered distal tip. It is available in 200 cm lengths. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating. The 200 cm length is compatible with a guidewire extension.
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K Number
K212211Device Name
Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter
Manufacturer
Vascular Solutions LLC
Date Cleared
2022-02-09
(209 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Vascular Solutions LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Turnpike catheters: The Turnpike catheters are intended to access discrete regions of the coronary and/or peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and to subselectively infuse/ deliver diagnostic and therapeutic agents, and to assist in crossing de novo coronary chronic total occlusions (CTO).
GuideLiner V3 catheter: GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature. to facilitate placement of interventional devices, and to assist in crossing de novo coronary chronic total occlusions (CTO).
TrapLiner catheter: The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, to facilitate the exchange of an interventional device while maintaining the position of a guidewire within the vasculature, and to assist in crossing de novo coronary chronic total occlusions (CTO).
Device Description
Turnpike catheters: The Turnpike catheters are single lumen catheters designed for use in the coronary and peripheral vasculature. The catheter shaft is constructed of two polymer layers that encapsulate a braid and a duallayer coil. The distal 60 cm of the Turnpike catheters are hydrophilic coated, and all models are compatible with 0.014" guidewires and 5F guide catheters. The turnpike catheters are available in four configurations: Turnpike, Turnpike Spiral, Turnpike Gold, and Turnpike LP.
GuideLiner V3 catheters: The GuideLiner V3 catheter is a rapid-exchange guide extension catheter designed for use in the coronary and peripheral vasculature. It is available in five sizes - 5F, 5.5F, 6F, 7F, and 8F. All sizes of the GuideLiner V3 catheter have a 150 cm working length, consisting of a 125 cm long stainless steel pushwire shaft followed distally by a 25 cm long full-round, silicone-wiped guide extension segment. The distal 17 cm of the 125 cm pushwire shaft is covered with a semicircular shaped polymer that meets the proximal end of the full-round guide extension segment.
TrapLiner catheters: The TrapLiner catheter is a rapid-exchange guide extension catheter with a trapping balloon on the distal end of the pushrod. The stainless steel hypotube pushrod is covered on the distal end by a semi-circular polymer ('half-pipe') and transitions to a hydrophilic coated full-round polymer guide extension section. There are two radiopaque marker bands on the guide extension segment, one on the distal tip and one on the collar. The Nylon trapping balloon (3.1 mm diameter) is located proximal to the half-pipe and has a single radiopaque gold marker under the proximal end of the balloon is reflowed, and an adhesive is applied on each end. The TrapLiner catheter has an over-molded Nylon hub on the proximal end to facilitate balloon inflation.
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K Number
K210647Device Name
SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter
Manufacturer
Vascular Solutions LLC
Date Cleared
2021-04-30
(58 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Vascular Solutions LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents.
Device Description
The SuperCross microcatheters are single lumen catheters designed for use in the coronary and/or peripheral vasculature. The SuperCross microcatheters provide guidewire support during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to distal vasculature. The SuperCross microcatheters are available in various tip configurations (straight, flexible, angled) and two working lengths (130cm, 150cm). The distal 40cm of the straight tip catheters and the distal 72 cm of the angled tip catheters has a hydrophilic coating. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing. The SuperCross microcatheters are compatible with .014" guidewires and 5F guide catheters.
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K Number
K193119Device Name
Twin-Pass Dual Access Catheter
Manufacturer
Vascular Solutions LLC
Date Cleared
2020-06-29
(230 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Vascular Solutions LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Twin-Pass catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.
Device Description
The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the peripheral and coronary vasculature. The Twin-Pass catheter consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment. The Twin-Pass catheter has a hydrophilic coating on the distal 18cm of the catheter. The Twin-Pass catheter has a working length of 135cm and have white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively. The Twin-Pass catheter has a platinum-iridium marker band located 1mm from the distal tip and a second platinum-iridium marker band located 11mm from the distal tip, identifying the distal end of the OTW lumen.
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K Number
K200720Device Name
D-Stat Radial Topical Hemostat
Manufacturer
Vascular Solutions LLC
Date Cleared
2020-06-26
(99 days)
Product Code
QSX, FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Vascular Solutions LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The D-Stat Radial Topical Hemostat is applied topically and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
Device Description
D-Stat Radial topical hemostat (D-Stat Radial) is a hemostatic band consisting of an application device containing a lyophilized pad consisting of thrombin, sodium carboxylmethylcellulose and calcium chloride in a nonwoven gauze, and an adjustable retention strap and attached foam pads. Hemostasis is achieved by the physiological coagulation-inducing properties of the lyophilized pad combined with the compression delivered by the application device.
The D-Stat Radial has been sterilized with irradiation.
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K Number
K191560Device Name
Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter
Manufacturer
Vascular Solutions LLC
Date Cleared
2019-08-09
(57 days)
Product Code
DQY, DOY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Vascular Solutions LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Turnpike catheters are intended to be used to access discrete regions of the coronary and/or peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and to subselectively infusedeliver diagnostic and therapeutic agents.
Device Description
The Turnpike catheters are single lumen catheters designed for use in the coronary and peripheral vasculature. The catheter's shaft is constructed of two polymer layers that encapsulate a braid and a dual-layer coil. The Turnpike catheters have a radiopaque tip (polymer or gold-plated) and are available in various tip and shaft configurations. The distal 60cm of each catheter has a hydrophilic coating. The Turnpike catheters are available in 135 cm or 150 cm working lengths and are compatible with 0.014" guidewires and 5F guide catheters.
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