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510(k) Data Aggregation
K Number
K133629Device Name
ANGIOJET ULTRA AVX THROMBECTOMY SET
Manufacturer
POSSIS MEDICAL, INC.
Date Cleared
2014-02-14
(80 days)
Product Code
QEW, DXE
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
POSSIS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits ≥ 3 mm in diameter.
Device Description
AngioJet Ultra AVX Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra AVX Thrombectomy Set is used with the AngioJet Ultra Console.
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K Number
K091593Device Name
ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS
Manufacturer
POSSIS MEDICAL, INC.
Date Cleared
2009-06-22
(20 days)
Product Code
QEZ
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
POSSIS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are intended for use with the Angiojet Ultra Console to break apart and remove thrombus from:
upper and lower extremity peripheral arteries ≥ 3.0mm in diameter,
upper extremity peripheral veins ≥ 3.0mm in diameter,
ileofemoral and lower extremity veins ≥ 3.0mm in diameter,
A-V access conduits ≥ 3.0mm in diameter and
for use with the Angiojet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
Device Description
AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are sterile, single use, disposable sets that include a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are used with the AngioJet Ultra Console.
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K Number
K090253Device Name
ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001
Manufacturer
POSSIS MEDICAL, INC.
Date Cleared
2009-04-08
(65 days)
Product Code
QEZ, DXE, KRA
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
POSSIS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from
- . Upper and Lower extremity peripheral arteries > 3 mm in diameter
- . Upper extremity peripheral veins > 3 mm in diameter
- Ileofemoral and lower extremity veins ≥ 3 mm in diameter .
- . AV access conduits > 3 mm in diameter and
- . For use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
The AngioJet Ultra Xpeedior Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from
- Upper and Lower extremity peripheral arteries ≥ 3 mm in diameter .
- Upper extremity peripheral veins > 3 mm in diameter .
- lleofemoral and lower extremity veins > 3 mm in diameter .
- . A V access conduits > 3 mm in diameter and
- For use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of ● physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
Device Description
AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are sterile, single use, disposable sets that include the AngioJet DVX and Xpeedior Thrombectomy catheters and a pump in one combined unit. The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are used with the AngioJet Ultra Console. A 3-port catheter manifold is used, so that contrast media and other fluids can be injected into the bloodstream where the catheter is positioned.
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K Number
K082382Device Name
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
Manufacturer
POSSIS MEDICAL, INC.
Date Cleared
2008-12-12
(115 days)
Product Code
QEZ, DXE, OEZ
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
POSSIS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits ≥ 3 mm in diameter.
Device Description
Each AngioJet Ultra AVX Thrombectorny Set is a sterile, single use, disposable set that includes the AngioJet AVX Thrombectomy catheter and pump in one combined unit. The AngioJet Ultra AVX Thrombectomy Set is used with the AngioJet Ultra Console. A 3-port catheter manifold is used, so that contrast media and other fluids can be injected into the vascular where the catheter is positioned.
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K Number
K081989Device Name
MODIFICATION TO FETCH ASPIRATION CATHETER
Manufacturer
POSSIS MEDICAL, INC.
Date Cleared
2008-09-26
(74 days)
Product Code
QEZ, DXE
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
POSSIS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fetch Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system and coronary vasculature.
Device Description
The FETCH Aspiration Catheter is a rapid exchange, low-profile tip, dual lumen catheter that uses a 0.014" (0.36 mm) guide wire to track to the target site. It is used for aspiration of fresh, soft emboli and thrombi Its outer diameter 0.052" (1.33 mm) or 4F allows advancement to the target site through a 6F (0.070" I.D.) guiding catheter. A radiopaque marker is located about 2 mm from the distal tip. FETCH is provided with an extension line, 30 cc syringe, one-way stopcock and a 40 micron collection basket. This basket can be used to filter aspirated blood for laboratory analysis of collected thrombus.
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K Number
K081454Device Name
GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE
Manufacturer
POSSIS MEDICAL, INC.
Date Cleared
2008-06-13
(21 days)
Product Code
MJN
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
POSSIS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GuardDOG® Occlusion System is indicated for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids, with or without vessel occlusion.
The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature.
Device Description
The GuardDOG System consists of two components: An Occlusion Guidewire and a carbon dioxide (CO2) Inflation Device. The GuardDOG Inflation Device is used to inflate the occlusion balloon and seal the guidewire once it is in position.
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K Number
K080806Device Name
ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608
Manufacturer
POSSIS MEDICAL, INC.
Date Cleared
2008-04-04
(14 days)
Product Code
QEZ, DXE
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
POSSIS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AngioJet Ultra Spiroflex VG Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 3 mm in diameter.
Device Description
Each AngioJet Ultra Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra Thrombectomy Set is used with the AngioJet Ultra Console.
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K Number
K073441Device Name
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
Manufacturer
POSSIS MEDICAL, INC.
Date Cleared
2008-01-24
(48 days)
Product Code
QEZ, DXE
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
POSSIS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits > 3.0mm in diameter.
Device Description
Each AngioJet Ultra Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra Thrombectomy Set is used with the AngioJet Ultra Console.
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K Number
K072769Device Name
ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS
Manufacturer
POSSIS MEDICAL, INC.
Date Cleared
2007-11-14
(47 days)
Product Code
QEZ, DXE
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
POSSIS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AngioJet Ultra XMI Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries ≥ 2 mm in diameter.
The AngioJet Ultra XVG Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 3mm in diameter.
The AngioJet Ultra Spiroflex Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 2mm in diameter.
Device Description
Each AngioJet Ultra Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra Thrombectomy Set is used with the AngioJet Ultra Console.
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K Number
K072269Device Name
ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552
Manufacturer
POSSIS MEDICAL, INC.
Date Cleared
2007-09-08
(24 days)
Product Code
QEZ, DXE, KRA
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
POSSIS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from upper and lower extremity peripheral arteries ≥3 mm in diameter; break apart and remove thrombus from upper extremity and infra-inguinal lower extremity peripheral veins ≥3 mm in diameter; and for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
Device Description
Each AngioJet Ultra DVX Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra DVX Thrombectomy Set is used with the AngioJet Ultra Console.
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