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510(k) Data Aggregation
K Number
K082199Device Name
SPIRALFUSE PERIPHERAL INFUSION SYSTEM
Manufacturer
BACCHUS VASCULAR, INC.
Date Cleared
2008-10-17
(74 days)
Product Code
QEY, KRA
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
BACCHUS VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SpiralFuse Peripheral Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Device Description
The SpiralFuse Peripheral Infusion System is a simpler version of the Trellis catheter that enables the physician to infuse fluids to a treatment region and disperse the fluid through a treatment region. The SpiralFuse is a multi-lumen catheter with an infusion lumen with holes located along the treatment zone to disperse the infused fluid. The other lumen is a through-lumen that is compatible with a 0.035" guidewire. The shaped infusion lumen is deployed once catheter position is achieved. The device is introduced through a standard 6F introducer sheath and passed over a 0.035" guidewire to the treatment site. Then, physicians will infuse fluid and allow it to disperse. Device removal is the same as the predicates.
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K Number
K071664Device Name
TRELLIS-6 PERIPHERAL INFUSION SYSTEM
Manufacturer
BACCHUS VASCULAR, INC.
Date Cleared
2007-07-13
(25 days)
Product Code
QEY, KRA
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
BACCHUS VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trellis™-6 Peripheral Infusion System is intended for controlled and selective infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.
Device Description
The Trellis-6 Peripheral Infusion System enables the physician to isolate a treatment region, infuse a physician-specified fluid, and disperse the fluid by means of oscillation of a Dispersion Wire. The Isolation/Infusion component is a multi-lumen catheter with two compliant balloons at the distal end and infusion holes located between these balloons. The device also has a central through-lumen that is compatible with a 0.035" guidewire. The Dispersion Wire provides oscillation when activated. The Dispersion Wire is connected to an integral Oscillation Drive Unit that oscillates the Dispersion Wire within the isolated region to further disperse the infused fluid. If desired by the physician, post procedure aspiration of the isolated area between the occluding balloons may be accomplished through the catheter by using the guidewire lumen.
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K Number
K050147Device Name
TRELLIS-8 PERIPHERAL INFUSION SYSTEM
Manufacturer
BACCHUS VASCULAR, INC.
Date Cleared
2005-02-03
(10 days)
Product Code
QEY, KRA
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
BACCHUS VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trellis™-8 Peripheral Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Device Description
The Trellis-8 Peripheral Infusion System enables the physician to isolate a treatment region, infuse a physician-specified fluid, and disperse the fluid by means of oscillation of a Dispersion Wire. The Isolation/Infusion component is a multi-lumen catheter with two compliant balloons at the distal end and infusion holes located between these balloons. The device also has a central through-lumen that is compatible with a 0.035" guidewire. The Dispersion Wire provides oscillation when activated. The Dispersion Wire is connected to an integral Oscillation Drive Unit that oscillates the Dispersion Wire within the isolated region to further disperse the infused fluid. If desired by the physician, post procedure aspiration of the isolated area between the occluding balloons may be accomplished through the catheter by using the guidewire lumen.
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K Number
K033997Device Name
SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110
Manufacturer
BACCHUS VASCULAR, INC.
Date Cleared
2004-02-04
(42 days)
Product Code
MCW
Regulation Number
870.4875Why did this record match?
Applicant Name (Manufacturer) :
BACCHUS VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Solera Plus Thrombectomy Catheter permits mechanical thrombectomy of synthetic dialysis grafts.
Device Description
The Solera Plus is a single-use, over-the-wire disposable catheter, with an integral Motor Drive Unit (MDU). The Solera Plus has a central hollow drive shaft connected to an expanding clot maceration and removal system. The clot removal system is comprised of a Nitinol macerator and a Nitinol outer protective basket. The macerator is attached to the drive shaft and rotates within the stationary protective basket. The protective basket expands to the lumen diameter and acts to protect the graft wall from the rotating macerator. Mechanical aspiration is achieved by rotation of the drive shaft and by an applied vacuum (locking syringe). The rotation of this drive shaft in conjunction with the vacuum causes material to be pumped out of the treatment area after maceration. Aspiration is controlled (i.e., on/off) by a button on the motor drive unit, which may be activated by the physician to allow flow out of the Solera Plus. The default position is 'off' to and is designed to minimize blood loss during the procedure.
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K Number
K032261Device Name
Trellis Reserve Infusion System
Manufacturer
BACCHUS VASCULAR, INC.
Date Cleared
2003-08-22
(30 days)
Product Code
QEY, KRA
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
BACCHUS VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trellis™ Reserve Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Device Description
The Trellis Reserve Infusion Catheter enables the physician to isolate a treatment region, infuse a physician-specified fluid, and disperse the fluid by means of oscillation of a Dispersion Wire. The Isolation/Infusion component is a multi-lumen catheter with two compliant balloons at the distal end and infusion holes located between these balloons. When inflated, the compliant balloons isolate a treatment zone to maintain concentration of the infused fluid. The device also has a central through-lumen that is compatible with a 0.035" guidewire. The Dispersion Wire component is a sheathed, shape-set Nitinol cable that provides oscillation when activated. The Dispersion Wire is connected to an integral Oscillation Drive Unit that oscillates the Dispersion Wire within the isolated region to further disperse the infused fluid. If desired by the physician, post procedure aspiration of the isolated area between the occluding balloons may be accomplished through the catheter by using the guidewire lumen.
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K Number
K022640Device Name
SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM
Manufacturer
BACCHUS VASCULAR, INC.
Date Cleared
2002-12-02
(116 days)
Product Code
MCW
Regulation Number
870.4875Why did this record match?
Applicant Name (Manufacturer) :
BACCHUS VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Solera Magnum Thrombectomy Catheter permits mechanical thrombectomy of synthetic dialysis grafts.
Device Description
The Solera Magnum is a single-use, over-the-wire disposable catheter, with an integral Motor Drive Unit (MDU). The Solera Magnum has a central hollow drive shaft connected to an expanding clot maceration and removal system. The clot removal system is comprised of a Nitinol macerator and a Nitinol outer protective basket. The macerator is attached to the drive shaft and rotates within the stationary protective basket. The protective basket expands to the lumen diameter and acts to protect the graft wall from the rotating macerator. Mechanical aspiration is achieved by rotation of the drive shaft and by an applied vacuum (locking syringe). The rotation of this drive shaft in conjunction with the vacuum causes material to be pumped out of the treatment area after maceration. Aspiration is controlled (i.e., on/off) by a button on the motor drive unit, which may be activated by the physician to allow flow out of the Solera Magnum. The default position is 'off' to and is designed to minimize blood loss during the procedure.
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K Number
K023514Device Name
TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH)
Manufacturer
BACCHUS VASCULAR, INC.
Date Cleared
2002-12-02
(42 days)
Product Code
QEY, KRA
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
BACCHUS VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trellis ™ Reserve Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Device Description
The Trellis Reserve Infusion Catheter enables the physician to isolate a treatment region, infuse a physician-specified fluid, and disperse the fluid by means of oscillation of a Dispersion Wire. The Isolation/Infusion component is a multi-lumen catheter with two compliant balloons at the distal end and infusion holes located between these balloons. When inflated, the compliant balloons isolate a treatment zone to maintain concentration of the infused fluid. The device also has a central through-lumen that is compatible with a 0.035" guidewire. The Dispersion Wire component is a sheathed, shape-set Nitinol cable that provides oscillation when activated. The Dispersion Wire is connected to an integral Oscillation Drive Unit which oscillates the Dispersion Wire up to 25 Hertz within the isolated region to further disperse the infused fluid. If desired by the physician, post procedure aspiration of the isolated area between the occluding balloons may be accomplished through the catheter by using the guidewire lumen.
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K Number
K021958Device Name
TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM (100CM CATHETER LENGTH 10CM INFUSION H
Manufacturer
BACCHUS VASCULAR, INC.
Date Cleared
2002-07-03
(19 days)
Product Code
QEY, KRA
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
BACCHUS VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trellis™ Plus Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Device Description
The Trellis Plus Infusion Catheter enables the physician to isolate a treatment region, infuse a physician-specified fluid, and disperse the fluid by means of oscillation of a Dispersion Wire. The Isolation/Infusion component is a multi-lumen catheter with two compliant balloons at the distal end and infusion holes located between these balloons. When inflated, the compliant balloons isolate a treatment zone to maintain concentration of the infused fluid. The device also has a central through-lumen that is compatible with a 0.035" guidewire. The Dispersion Wire component is a sheathed, shape-set Nitinol cable that provides oscillation when activated. The Dispersion Wire is connected to an integral Oscillation Drive Unit which oscillates the Dispersion Wire up to 25 Hertz within the isolated region to further disperse the infused fluid.
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K Number
K013635Device Name
TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH)
Manufacturer
BACCHUS VASCULAR, INC.
Date Cleared
2002-02-11
(98 days)
Product Code
QEY, KRA
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
BACCHUS VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trellis™ Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Device Description
The Trellis Infusion Catheter enables the physician to isolate a treatment region, infuse a physician-specified fluid, and disperse the fluid by means of oscillation of a Dispersion Wire. The Isolation/Infusion component is a multi-lumen catheter with two compliant balloons at the distal end and infusion holes located between these balloons. When inflated, the compliant balloons isolate a treatment zone to maintain concentration of the infused fluid. The device also has a central through-lumen that is compatible with a 0.035" guidewire. The Dispersion Wire component is a sheathed, shape-set Nitinol cable that provides oscillation when activated. The Dispersion Wire is connected to an integral Oscillation Drive Unit which oscillates the Dispersion Wire up to 25 Hertz within the isolated region to further disperse the infused fluid.
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K Number
K003570Device Name
BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755
Manufacturer
BACCHUS VASCULAR, INC.
Date Cleared
2001-06-06
(198 days)
Product Code
MCW
Regulation Number
870.4875Why did this record match?
Applicant Name (Manufacturer) :
BACCHUS VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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