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510(k) Data Aggregation

    K Number
    K150932
    Device Name
    Sheath Introducer
    Manufacturer
    BIOTEQUE CORP.
    Date Cleared
    2016-07-22

    (473 days)

    Product Code
    DRE
    Regulation Number
    870.1310
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOTEQUE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bioteq Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
    Device Description
    Bioteq Sheath Introducer consists of a sheath introducer with side port extension and stopcock. The sheath hub includes a hemostasis valve and a suture ring. A 4-way stopcock is affixed to the proximal end of the side port extension. The Bioteq Sheath Introducer assembly includes a vessel dilator that rotates securely with the sheath introducer hub and guidewire which is cleared by the Food and Drug Administration (K920884). The sheath introducer is available in 5 French (F) to 7F sizes in length of 11cm or 23cm. The vessel dilator is tipped specifically to accept either a 0.038 inch or a 0.035 inch diameter guidewire with the length of 45cm or 80cm.
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    K Number
    K102633
    Device Name
    BIOTEQ ANGIOGRAPHIC CATHETER
    Manufacturer
    BIOTEQUE CORP.
    Date Cleared
    2011-09-09

    (361 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOTEQUE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The "BIOTEQ" Angiographic Catheter is indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system. The device is for use in the coronary and peripheral vasculature, and not for use in the neurovasculature.
    Device Description
    The BIOTEO® ANGIOGRAPHIC CATHETER is with the braided proximal shaft. The distal shaft of the catheter has variety configuration and the tip is made soft to minimize trauma to the vessel wall. It consists of the following major components: Soft Tube, Braiding tube, Screw Cap, F.L.L. Adapter, Adaptor Butterfly.
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    K Number
    K033862
    Device Name
    BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK
    Manufacturer
    BIOTEQUE CORP.
    Date Cleared
    2005-02-14

    (430 days)

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

    BIOTEQUE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BIOTEQ® Pigtail Drainage Catheter Set( One Step Type) is intended to be used for percutaneous drainage of abscesses, cysts, gall bladders and nephrostomies.
    Device Description
    The BIOTEQ® Pigtail Drainage Catheter Set ( One Step Type) is used for the drainage pathway of patients' fluids through the catheter out of body . It consist of the following major components: ① F.L.L. Adapter ② Screw Cap ③ Catheter ④ Curve Straightener (Sleeve) ⑤ Wire Cap --- (For With Safety String Lock model only) ⑥ Trocar Stylet ⑦ Trocar Needle ⑧ Sheath ⑨ Suture Wire --- (For With Safety String Lock model only)
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    K Number
    K033210
    Device Name
    BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET
    Manufacturer
    BIOTEQUE CORP.
    Date Cleared
    2004-12-30

    (454 days)

    Product Code
    FAD
    Regulation Number
    876.4620
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOTEQUE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET is intended to facilitate the temporary internal drainage of urine from the kidney to the bladder via placement endoscopically by a trained physician.
    Device Description
    The BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET consist of a ureter stent that is completely radiopaque, coiled cylindrical or open tip with drainage holes at intervals of 5-20 mm, centimeter graduations, continuous black positioning line to indicate the direction in which the catheter tip coils, and black marking at the catheter end. The Pusher Catheter (Introducer sheath) is approximately 45cm long. The Guide Wire (Spiral stylet) is made of stainless steel with PTFE coating and a flexible safety tip and a marked rigid tip and is approximately 120 cm long. The plastic dispenser is used to protect the Guide Wire (Spiral stylet). There are also plastic clips in the set.
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    K Number
    K032292
    Device Name
    BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX
    Manufacturer
    BIOTEQUE CORP.
    Date Cleared
    2004-03-22

    (242 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOTEQUE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BIOTEQ® Arterial-Venous Fistula (A.V.F) Needle Set with Safety Flex is used for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended for single use only and is for temporary catheterization of less than 30 days. The Safety Feature(Safety Flex) aids in prevention of needle-sticks injuries when removing and discarding needles after dialysis session.
    Device Description
    The BIOTEQ® A. V. FISTULA NEDDLE SET WITH SAFETY FLEX consists of the following major components: ① Protection Cap ② Needle Cannula ③ Butterfly Wing ④ Needle Hub ⑤ Safety Flex ⑥ Small Pinch Clamp ⑦ PVC Tubing ⑧ Female Luer ⑨ Cap for Female Luer These components assembled together as BIOTEQ® Arterial-Venous Fistula (A.V.F) Needle Set with Safety Flex for use during hemodialysis procedures. The Safety Feature(Safety Flex) aids in prevention of needle-sticks injuries when removing and discarding needles after dialysis session. Various models of needle size manufactured such as 14 gauge, 15 gauge, 16 gauge, 17 gauge.
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    K Number
    K013634
    Device Name
    BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK
    Manufacturer
    BIOTEQUE CORP.
    Date Cleared
    2002-07-09

    (246 days)

    Product Code
    FJK
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOTEQUE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs ( BT-102DA · BT-102DB · BT-102DC · BT-102DD) are sets of single-use disposable components intended to provide extracorporeal access to blood of patients suffering from end stage renal disease during Hemodialysis therapy. Each set will include an arterial/venous bloodline set, and any combination of two or three component of the following items: An intravenous administration set for (use in administration of intravenous fluids to a dialysis set in conjunction with hemodialysis procedures.) , AV fistula needle set to (apply on the access site of patient vessel to draw the blood flow adequate to pass through the dialyer and reinfusion of dialysed blood back to patient vessel via the A.V. Fistula Needle Set during hemodialysis procedures.) , and/or A transducer protector for (use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway).
    Device Description
    The BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs (BT-102DA 、BT-102DB、BT-102DC、BT-102DD) are sets of single-use disposable components intended to provide extracorporeal access to blood of patients suffering from end stage renal disease during Hemodialysis therapy. Each set will include an arterial/venous bloodline set, and any combination of two or three component of the following items: An intravenous administration set for use in administration of intravenous fluids to a dialysis set in conjunction with hemodialysis procedures. , AV fistula needle set to apply on the access site of patient vessel to draw the blood flow adequate to pass through the dialyer and reinfusion of dialysed blood back to patient vessel via the A.V. Fistula Needle Set during hemodialysis procedures. , and/or A transducer protector for use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway. BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs includes 4 models (BT-102DA 、BT-102DB、BT-102DC、BT-102DD)
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    K Number
    K012526
    Device Name
    BIOTEQUE SCALP VEIN SET
    Manufacturer
    BIOTEQUE CORP.
    Date Cleared
    2001-09-14

    (39 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOTEQUE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BIOTEQ® SCALP VEIN SET act as a pathway to administer parenteral fluid/ medication into the patient's vascular system.
    Device Description
    BIOTEQ® SCALP VEIN SET (BS-120 (22G); BS-121(23G) ; BS-122(24G))consist of the following 5 major components: Protective cap for needle, the stainless needle, the plastic butterfly wing , the PVC Tube, the PVC safety Cap. These 5 major components assembled together as SCALE VEIN SET for use as a pathway to administer medical fluid from extracorporeal system through the device into venous blood.
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    K Number
    K002449
    Device Name
    BIOTEQ I.V. (INTRAVENOUS) SET
    Manufacturer
    BIOTEQUE CORP.
    Date Cleared
    2000-12-22

    (135 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOTEQUE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992930
    Device Name
    BIOTEQUE HEMODIALYSIS BLOOD TUBING SET
    Manufacturer
    BIOTEQUE CORP.
    Date Cleared
    2000-02-09

    (162 days)

    Product Code
    FJK
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOTEQUE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BIOTEQUE Hemodialysis Blood Tubing Set(Models BT-102A, BT-102B and BT-190) is intended to serve as a conduit through which blood is taken from the patient, delivered to the dialyzer, and returned to the patient during hemodialysis therapy. The device is intended to be used for patients suffering from renal disease only.
    Device Description
    Bioteque Hemodialysis Blood Tubing Set, consists of Arterial Line & Venous Line, is used as the conduit through which blood is taken from the patient, delivered to the dialyzer, and returned to the patient during dialysis therapy.
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    K Number
    K993118
    Device Name
    BIOTEQUE A.V. FISTULA NEEDLE SET
    Manufacturer
    BIOTEQUE CORP.
    Date Cleared
    1999-12-17

    (88 days)

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

    BIOTEQUE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bioteque A.V. Fistula Needle is used during hemodialysis. It's a part of accessory of extracorporeal system for treatment of renal failure. A.V. Fistula Needle applied on the access site of patient's vessel to obtain blood flow adequate to pass through the dialyses, and the reinfusion of dialysed blood back to patient via the fistula needle during hemodialysis.
    Device Description
    Bioteque A.V. Fistula Needle Set consist of the following 6 major components: the stainless needle, protector cap for needle, the plastic butterfly wing, the PVC tubing, the female luer, the cap for female luer. These 6 major components assembled together as A.V. Fistula Needle Set for use during hemodialysis procedures. Various models of needle size manufactured such as 14 gauge, 15 gauge, 16 gauge.
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