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510(k) Data Aggregation
K Number
K150932Device Name
Sheath Introducer
Manufacturer
BIOTEQUE CORP.
Date Cleared
2016-07-22
(473 days)
Product Code
DRE
Regulation Number
870.1310Why 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
K102633Device Name
BIOTEQ ANGIOGRAPHIC CATHETER
Manufacturer
BIOTEQUE CORP.
Date Cleared
2011-09-09
(361 days)
Product Code
DQO
Regulation Number
870.1200Why 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
K033862Device 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
876.5010Why 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
K033210Device Name
BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET
Manufacturer
BIOTEQUE CORP.
Date Cleared
2004-12-30
(454 days)
Product Code
FAD
Regulation Number
876.4620Why 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
K032292Device 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
880.5200Why 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
K013634Device Name
BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK
Manufacturer
BIOTEQUE CORP.
Date Cleared
2002-07-09
(246 days)
Product Code
FJK
Regulation Number
876.5820Why 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
K012526Device Name
BIOTEQUE SCALP VEIN SET
Manufacturer
BIOTEQUE CORP.
Date Cleared
2001-09-14
(39 days)
Product Code
FPA
Regulation Number
880.5440Why 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
K002449Device Name
BIOTEQ I.V. (INTRAVENOUS) SET
Manufacturer
BIOTEQUE CORP.
Date Cleared
2000-12-22
(135 days)
Product Code
FPA
Regulation Number
880.5440Why 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
K992930Device Name
BIOTEQUE HEMODIALYSIS BLOOD TUBING SET
Manufacturer
BIOTEQUE CORP.
Date Cleared
2000-02-09
(162 days)
Product Code
FJK
Regulation Number
876.5820Why 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
K993118Device Name
BIOTEQUE A.V. FISTULA NEEDLE SET
Manufacturer
BIOTEQUE CORP.
Date Cleared
1999-12-17
(88 days)
Product Code
FIE
Regulation Number
876.5540Why 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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