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510(k) Data Aggregation
K Number
K042370Device Name
TORAYGUIDE GUIDEWIRE
Manufacturer
TORAY INDUSTRIES (AMERICA), INC.
Date Cleared
2004-12-17
(108 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
TORAY INDUSTRIES (AMERICA), INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TORAYGuide guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the heart and peripheral vasculature. The device is not intended for use in the coronary arteries.
Device Description
The TORAYGUIDE™ Guidewire is manufactured of 304 stainless steel, which is consistent with guidewires presently in commercial distribution and with the same intended use. The device diameter is 0.65 mm, and is supplied in lengths ranging from 175 to 230 cm. The guidewire has a spring core at the distal end, also of stainless steel. The device is ethylene oxide sterilized and intended for single use only.
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K Number
K030050Device Name
TORAYSULFONE DIALYZER, BS-L SERIES
Manufacturer
TORAY INDUSTRIES (AMERICA), INC.
Date Cleared
2003-09-29
(266 days)
Product Code
KDI
Regulation Number
876.5860Why did this record match?
Applicant Name (Manufacturer) :
TORAY INDUSTRIES (AMERICA), INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Toraysulfone™ Dialyzer, BS-L Series, is indicated for use in hemodialysis treatment of patients with acute or chronic renal failure.
Device Description
The Toraysulfone Dialyzer, BS-L Series consists of highly permeable polysulfone hollow fibers housed in a polystyrene casing and secured at each end with polystyrene headers. High permeability dialyzers must be used only in conjunction with dialysis machines equipped with an ultrafiltration controller. The Toraysulfone Dialyzer, BS-L Series is provided in a range of three sizes based on the surface area of the hollow fiber membrane. The device is gammaray sterilized and intended for single use only.
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K Number
K002512Device Name
TORAYSULFONE DIALYZER
Manufacturer
TORAY INDUSTRIES (AMERICA), INC.
Date Cleared
2001-10-15
(426 days)
Product Code
KDI
Regulation Number
876.5860Why did this record match?
Applicant Name (Manufacturer) :
TORAY INDUSTRIES (AMERICA), INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994198Device Name
HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L
Manufacturer
TORAY INDUSTRIES (AMERICA), INC.
Date Cleared
2000-08-25
(256 days)
Product Code
KDI
Regulation Number
876.5860Why did this record match?
Applicant Name (Manufacturer) :
TORAY INDUSTRIES (AMERICA), INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hemofeel™-CH hemofilter is indicated for use in the prevention or treatment of fluid overload, electrolyte and acid/base imbalances in cases of acute renal failure or toxemia with oliguria or anuria. It may also be used when removal of excess fluid is indicated, such as patients in pulmonary edema or congestive heart failure refractory to diuretic therapy.
Device Description
The Hemofeel-CH Hemofilter consists of highly permeable polymethylmethacrylate (PMMA) hollow fibers housed in a polystyrene casing and secured at each end with polystyrene headers. Blood enters the device through the arterial inlet port, passes through the hollow fibers and exits at the opposite end through the venous outlet port. The Hemofeel-CH hemofilter is provided in a range of sizes based on the surface area of the hollow fiber membrane. Hemofilter size should be selected by the physician according to the patient's body weight and medical condition. The device is gamma-ray sterilized and intended for single use only.
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