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510(k) Data Aggregation

    K Number
    K972521
    Device Name
    NAVIGATOR (STYLET) 2006
    Manufacturer
    SIL-MED CORP.
    Date Cleared
    1997-10-01

    (86 days)

    Product Code
    GAH
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIL-MED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Navigator (stylet) is a stainless steel wire rod, inserted into the catheter to assist with insertion and placement of the catheter in the peritoneum.
    Device Description
    Stainless steel wire rod intended to aid in the manipulation of or insertion of the catheter for placement in the peritoneum.
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    K Number
    K961392
    Device Name
    ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II
    Manufacturer
    SIL-MED CORP.
    Date Cleared
    1997-07-18

    (463 days)

    Product Code
    FJS
    Regulation Number
    876.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIL-MED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Peritoneal Dialysis Coil Catheter with Spi-Argent™II, for the transport of dialysate solution to and from the peritoneal cavity for treatment of renal failure; suitable for CAPD (Continuous Ambulatory Peritoneal Dialysis)
    Device Description
    Peritoneal Dialysis Coil Catheter with Spi-Argent™II, for the transport of dialysate solution to and from the peritoneal cavity for treatment of renal failure; suitable for CAPD (Continuous Ambulatory Peritoneal Dialysis). Peritoneal Dialysis Coil Catheter with Spi-Argent™ll is the same as the Peritoneal Dialysis Coil Catheter, K850247 except for the Spi-Argent™ II option offering. Spi-Argent™ II is the same surface treatment as the K942709, Mediastinal Drain with Spi-Argent™ II. The Spi-Argent™II surface treatment provides a lubricious surface to ease insertion and removal of the catheter.
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    K Number
    K961194
    Device Name
    ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN
    Manufacturer
    SIL-MED CORP.
    Date Cleared
    1996-08-08

    (134 days)

    Product Code
    GBW
    Regulation Number
    878.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIL-MED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Catheter for drainage of blood and fluid from mediastinum after chest surgery and/or trauma; for use with suction apparatus
    Device Description
    Silicone perforated tubing, flattened profile, blue radiopaque stripe; surface treated to reduce friction and Antimicrobial; perforations ("eyes") on both flattened surfaces of tubing; external end has cutaway adapter; imprinted with drain size
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    K Number
    K961295
    Device Name
    SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR
    Manufacturer
    SIL-MED CORP.
    Date Cleared
    1996-06-26

    (83 days)

    Product Code
    GBX
    Regulation Number
    878.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIL-MED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For post-operative drainage of serosanguineous fluids and blood away from operative site; for use with suction reservoir as a closed wound drain system
    Device Description
    Two joined silicone tubing sections; flat drain section is partially perforated for fluid collection, is ribbed to prevent collapse as suction is applied, and has blue radiopaque stripe; round tubing is connected to suction reservoir inlet; offered with an introduction Trocar attached as an option; silver ion surface treated to ease insertion and removal.
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    K Number
    K960099
    Device Name
    PENROSE DRAIN MODELS 6001 - 6007
    Manufacturer
    SIL-MED CORP.
    Date Cleared
    1996-03-11

    (60 days)

    Product Code
    GCY
    Regulation Number
    878.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIL-MED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Post-operative passive drainage of serosanguineous fluids away from soft tissue operative site.
    Device Description
    Passive Wound Drain. Flat Silicone Drain. Dimensionally equivalent to the Davol Gravity Drain, except Davol offers both 12" and 18"; Sil-Med Corporation offers 18" only. Both have inner diameter teeth to prevent the drain from collapsing. Both devices have a Radiopaque stripe. Sil-Med Penrose Drains are sold sterile only.
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    K Number
    K955463
    Device Name
    GRIP-A-BOOTS
    Manufacturer
    SIL-MED CORP.
    Date Cleared
    1996-01-23

    (55 days)

    Product Code
    LXZ
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIL-MED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K942709
    Device Name
    MEDIASTINAL SILICONE DRAINS
    Manufacturer
    SIL-MED CORP.
    Date Cleared
    1996-01-04

    (575 days)

    Product Code
    GBW
    Regulation Number
    878.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIL-MED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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