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510(k) Data Aggregation

    K Number
    K152485
    Device Name
    FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm
    Manufacturer
    Date Cleared
    2016-02-16

    (169 days)

    Product Code
    Regulation Number
    870.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTIAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FLASH Mini Ostial System is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The FLASH Mini Ostial System is also indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature.
    Device Description
    The FLASH Mini Ostial System is a 0.014" guidewire-compatible, rapid exchange (RX) coronary angioplasty balloon catheter with a working length of 135cm. The FLASH Mini Ostial System uses a dual balloon design that features a complaint Proximal Balloon which prevents distal migration of the balloon during angioplasty. The second semi-compliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion. The FLASH Mini Ostial System is packaged with two accessory syringes. A standard 10cc syringe intended for use in deflation of the Proximal Balloon and a 1.0cc syringe with a pressure relief feature intended for use in inflation of the Proximal Balloon. The pressure relief feature is intended to improve patient safety by limiting the maximum achievable pressure in the Proximal Balloon if the user attempts to inflate the Proximal Balloon when incorrectly positioned.
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    K Number
    K150946
    Device Name
    FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm
    Manufacturer
    Date Cleared
    2015-05-08

    (30 days)

    Product Code
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTIAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FLASH Ostial System OTW is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.
    Device Description
    The Flash Ostial System OTW is designed for the dilatation of stenotic ostial lesions in the peripheral vasculature. The FLASH Ostial System OTW is a 0.035" guidewire-compatible, over the wire (OTW) angioplasty balloon catheter with proximal anchoring and a working length of either 80cm or 135cm. All device sizes in the Flash Ostial System OTW product family are designed to be compatible with 6F guiding sheaths. The FLASH Ostial System OTW uses a dual balloon design that features a compliant proximal balloon, which prevents distal migration of the balloon during angioplasty. The second semi-compliant higher-pressure distal balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.
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    K Number
    K133861
    Device Name
    FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM
    Manufacturer
    Date Cleared
    2014-07-02

    (195 days)

    Product Code
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTIAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FLASH Ostial System OTW is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.
    Device Description
    The Flash Ostial System OTW is a 0.035" guidewire-compatible, over the wire (OTW) angioplasty balloon catheter with proximal anchoring and a working length of either 80cm or 135cm. The FLASH Ostial System OTW uses a dual balloon design that features a compliant anchoring balloon, which prevents distal migration of the balloon during angioplasty. The second semi-compliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.
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    K Number
    K131450
    Device Name
    FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0
    Manufacturer
    Date Cleared
    2013-08-06

    (78 days)

    Product Code
    Regulation Number
    870.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTIAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FLASH Mini Ostial System is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The FLASH Mini Ostial System is also indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature.
    Device Description
    The FLASH Mini Ostial System is a .014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring and a working length of 135cm. The FLASH Mini Ostial System uses a dual balloon design that features a compliant anchoring balloon, which prevents distal migration of the balloon during angioplasty. The second semicompliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.
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    K Number
    K122178
    Device Name
    FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1
    Manufacturer
    Date Cleared
    2012-10-11

    (80 days)

    Product Code
    Regulation Number
    870.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTIAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Flash-C PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The Flash-C PTCA Balloon Dilatation Catheter is also indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature.
    Device Description
    The Flash-C PTCA Balloon Dilatation Catheter is a .014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring and a working length of 135cm. The Flash-C PTCA Balloon Dilatation Catheter uses a dual balloon design that features a compliant anchoring balloon, which prevents distal migration of the balloon during angioplasty. The second semi-compliant higherpressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.
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    K Number
    K122379
    Device Name
    FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM
    Manufacturer
    Date Cleared
    2012-09-05

    (30 days)

    Product Code
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTIAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Flash PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.
    Device Description
    The Flash PTA Balloon Dilatation Catheter is designed for the dilation of stenotic ostial lesions in the peripheral vasculature. The Flash PTA Balloon Dilatation Catheter is a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The Flash PTA Balloon Dilatation Catheter uses a dual balloon design, which prevents distal migration of the balloon during angioplasty. The distal semi-compliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.
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    K Number
    K113582
    Device Name
    ARCHSTENT BILIARY SYSTEM
    Manufacturer
    Date Cleared
    2012-06-29

    (207 days)

    Product Code
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTIAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ArchStent Biliary system is intended for use in the palliation of malignant neoplasms in the biliary tree
    Device Description
    The ArchStent Biliary System is a 0.014" guidewire-compatible, rapid exchange (RX) balloonexpandable stent system. It consists of a stainless steel stent that can flare in the proximal segment and a dual balloon delivery catheter. Accessories include a 1.0 cc Syringe and a 10 cc Deflation Syringe.
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    K Number
    K113775
    Device Name
    FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM
    Manufacturer
    Date Cleared
    2012-06-29

    (190 days)

    Product Code
    Regulation Number
    870.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTIAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Flash-C PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion.
    Device Description
    The Flash-C PTCA Balloon Dilatation Catheter is a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The device uses a dual balloon design featuring a compliant anchoring balloon, which enables the operator to precisely position the catheter at aorto-ostial anatomies and prevent distal migration of the balloon during angioplasty. The second semi-compliant high pressure balloon allows for luminal dilatation.
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    K Number
    K121175
    Device Name
    FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM
    Manufacturer
    Date Cleared
    2012-06-29

    (72 days)

    Product Code
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTIAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Flash PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.
    Device Description
    The Flash PTA Balloon Dilatation Catheter is designed for dilation of stenotic ostial lesions in the peripheral vasculature. The Flash PTA Balloon Dilatation Catheter is a .014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring and a working length of 135cm. The Flash PTA Balloon Dilatation Catheter uses a dual balloon design that features a compliant anchoring balloon, which prevents distal migration of the balloon during angioplasty. The second semicompliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.
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    K Number
    K120738
    Device Name
    FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM
    Manufacturer
    Date Cleared
    2012-03-29

    (17 days)

    Product Code
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTIAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Flash PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This catheter is not intended for use in coronary arteries.
    Device Description
    The Flash PTA Balloon Dilatation Catheter is a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The device uses a dual balloon design featuring a compliant anchoring balloon, which enables the operator to precisely position the catheter at aorto-ostial anatomies and prevent distal migration of the balloon during angioplasty. The second semi-compliant high pressure balloon allows for luminal dilatation.
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