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510(k) Data Aggregation

    K Number
    K073092
    Device Name
    DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40,
    Manufacturer
    SPIRE BIOMEDICAL INC
    Date Cleared
    2008-01-29

    (89 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIRE BIOMEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Spire Biomedical, Inc.'s Decathlon™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane catheter designed for percutaneous insertion via cutdown. Catheters longer than 40cm are intended for femoral vein insertion.
    Device Description
    The Decathlon™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is constructed of radiopaque medical grade polyurethane. To reduce recirculation during hemodialysis. the arterial lumen of the catheter is shorter than the venous lumen at the catheter's distal end. The catheter has a felt cuff and dual extensions. Each extension has a color coded luer lock adaptor, red for arterial and blue for venous lumen determination. Additionally, each extension has a clamp.
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    K Number
    K073093
    Device Name
    DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,
    Manufacturer
    SPIRE BIOMEDICAL INC
    Date Cleared
    2008-01-22

    (82 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIRE BIOMEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Spire Biomedical, Inc.'s Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic Hemodialysis and apheresis. It is a radiopaque polyurethane catheter with a heparin coating, designed for percutaneous insertion or insertion via a cutdown. The ability of the Carmeda® End-Point Bonded heparin coating to reduce clotting is supported by in-vitro and animal testing. Catheters longer than 40cm are intended for femoral vein insertion.
    Device Description
    The Decathlon™ Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is constructed of radiopaque medical grade polyurethane. To reduce recirculation during hemodialysis, the arterial lumen of the catheter is shorter than the catheter's distal end. The catheter has a felt cuff and dual extension has a color coded luer lock adaptor, red for arterial and blue for venous lumen determination. Additionally, each extension has a clamp.
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    K Number
    K063441
    Device Name
    15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55
    Manufacturer
    SPIRE BIOMEDICAL INC
    Date Cleared
    2007-02-12

    (90 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIRE BIOMEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Spire Biomedical Inc's Alta Gold, Coated Twin Lumen Chronic Indications for Use: Hemodialysis Catheter with fixed tips is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane with a heparin coating, designed for percutaneous insertion or insertion via cutdown. The ability of the Carmeda End point Bonded Heparin Coating to reduce clotting is supported by in-vitro testing. Catheters longer than 40cm are intended for femoral vein insertion.
    Device Description
    Spire Biomedical, Inc.'s 15.5Fr Alta Gold, Twin Lumen Fixed Tip Coated Chronic Hemodialysis Catheter is processed with a proprietary Carmeda® BioActive Surface (CBAS®) coating technology that attaches a functionally active heparin to the surfaces of the device. The coating counteracts thrombus from forming on the catheter. Spire's 15.5Fr Alta Gold, Heparin Coated Catheter is fully coated with CBAS® on the internal surface and on the external surface of the catheter body (from 2cm distal to the ends of the distal tips; the cuff is not coated). The coating is essentially non-leaching. Additionally, the maximum amount of heparin on the surface is only 1mg. Therefore; the effects of the entire coating on a patient's coagulation status would be insignificant.
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    K Number
    K063431
    Device Name
    15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40
    Manufacturer
    SPIRE BIOMEDICAL INC
    Date Cleared
    2007-01-29

    (77 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIRE BIOMEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Spire Biomedical Inc's Decathlon Gold, Coated Twin Lumen Chronic Hemodialysis Catheter with separated funnel tips is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane with a heparin coating, designed for percutaneous insertion or insertion via cutdown. The ability of the Carmeda® End point Bonded Heparin Coating to reduce clotting is supported by invitro testing. Catheters longer than 40cm are intended for femoral vein insertion.
    Device Description
    Spire Biomedical, Inc.'s 15.5Fr Decathlon Gold, Coated catheters are processed with a proprietary Carmeda® BioActive Surface (CBAS®) coating technology that attaches a functionally active heparin to the surfaces of the coating counteracts thrombus from forming on the catheter. Spire's 15.5Fr Decathlon Gold. Coated catheters are fully coated with CBAS® on the internal surface and on the external surface of the catheter body (from 2cm distal to the cuff to the ends of the distal tips; the cuff is not coated). The distal ends of this catheter have the arterial and venous tips rounded and "funneled" for easier over the wire insertion. It has one elliptical side hole placed on the distal ends of the arterial and venous lumens. A stylet will be preloaded in the arterial lumen for ease of guidewire placement. The coating is essentially non-leaching. Additionally, the maximum amount of heparin on the surface is only 1mg. Therefore; the effects of the entire coating on a patient's coagulation status would be insignificant.
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    K Number
    K041559
    Device Name
    55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55
    Manufacturer
    SPIRE BIOMEDICAL INC
    Date Cleared
    2004-07-30

    (50 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIRE BIOMEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 55cm Pourchez RetrO Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown. Catheters longer than 40cm can be used for femoral insertion.
    Device Description
    55cm Pourchez RetrO™ Silicone Twin Lumen Chronic Device Hemodialysis Catheter with Separated Tips. The 55cm Pourchez RetrO catheter uses the exact same materials of construction.
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    K Number
    K040509
    Device Name
    ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40
    Manufacturer
    SPIRE BIOMEDICAL INC
    Date Cleared
    2004-04-19

    (52 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIRE BIOMEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 15.5Fr Alta LR Twin Lumen Fixed Tip Hemodialysis Catheter is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.
    Device Description
    The polyurethane 15.5Fr Alta LR Twin Lumen Fixed Tip Chronic Hemodialysis Catheter is a product line extension of Spire Biomedical, Inc.'s Decathlon ™ radiopaque polyurethane catheters with similar catheter tip-to-hub lengths of 24cm, 28cm, 32cm, 36cm and 40cm.
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    K Number
    K022000
    Device Name
    POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES)
    Manufacturer
    SPIRE BIOMEDICAL INC
    Date Cleared
    2002-07-19

    (30 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIRE BIOMEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Spire Biomedical, Inc.'s Pourchez RetrO™ Silicone Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic hemodialysis and apheresis. It is a radiopaque silicone catheter designed for percutaneous insertion or insertion via a cutdown.
    Device Description
    The Pourchez RetrO™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is a flexible radiopaque silicone catheter. The distal end has two tips separated over a predetermined distance. The distal arterial and venous lumens are round and are staggered to reduce recirculation. The body is oval, and the proximal end, which is connected to the catheter body by color-coded extension adapters, has two distinctive lumens with color-coded adapters (red for arterial and blue for venous). The catheter is available in five different implant lengths. It is also available with and without side holes on the distal ends. The catheter has a polyester cuff located at one of five different implant lengths from the distal end. A RetrO catheter repair kit will also be offered to replace damaged extensions and/or extension adapters.
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    K Number
    K021212
    Device Name
    24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS
    Manufacturer
    SPIRE BIOMEDICAL INC
    Date Cleared
    2002-05-17

    (30 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIRE BIOMEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pourchez XpressO™ is a silicone twin lumen catheter with separated tips designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.
    Device Description
    The 24cm tip to hub length Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is a product line extension of Spire Biomedical, Inc.'s the Pourchez XpressO™ flexible radiopaque silicone catheters. The 24cm catheter supplements the other four tip to hub length catheters (28cm, 32cm, 36cm and 40cm) catheters. The 24cm is also available with and without side holes on the distal ends.
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    K Number
    K013160
    Device Name
    POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER
    Manufacturer
    SPIRE BIOMEDICAL INC
    Date Cleared
    2002-04-11

    (202 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIRE BIOMEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pourchez XpressO™ Catheter is designed for chronic (longterm) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown into the jugular or subclavian vein. The Pourchez Xpresso™ is a silicone twin lumen catheter with separated tips designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.
    Device Description
    The Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is a flexible radiopaque silicone catheter. The distal end has two tips separated over a predetermined distance. The distal arterial and venous lumens are round and are staggered to reduce recirculation. The body is oval, and the proximal end has two distinctive lumens with color-coded adapters (red for arterial and blue for venous). The catheter is available in four different tip-to-hub lengths. It is also available with and without side holes on the distal ends. The catheter has a polyester cuff located at one of four different locations from the distal end.
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