Search Results
Found 3 results
510(k) Data Aggregation
K Number
K024007Device Name
SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J
Manufacturer
SUNDER BIOMEDICAL TECH. CO., LTD.
Date Cleared
2003-07-14
(222 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
SUNDER BIOMEDICAL TECH. CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The triple lumen central venous Catheter is intended for vascular access infusion and withdrawal of blood, blood products, and fluids, central venous blood pressure monitoring and continuous or intermittent drug infusion.
- Patients requiring multiple sites for IV access.
- Patients lacking useable peripheral IV sites.
- Patients requiring central venous pressure monitoring.
- Patients requiring total parenteral nutrition.
- Patients receiving incompatible medications.
- Patients requiring multiple infusions of fluids, medications, or chemotherapy.
- . Patients subject to frequent blood sampling or receiving blood transfusions.
- Patients receiving infusions that are hypertonic, hyperosmolar or infusions that have divergent pH values.
Device Description
The medical device made by Sunder Biomedical Tech, CO., LTD are triple-lumen. polyurethane catheter, 5.5 and 7.0 French in size, with three independent non-communication lumens, extension lines, luer hubs and slide clamps, placed within a vein and whose distal end is intended to be located within the vena cava (inferior of superior). Central Venous Catheter (CVC) - a tubular device with single lumen or rnulti-lumen catheter, or cannula, placed within a vein and whose distal end is intended to be located within the vena cava (inferior of superior).
The catheterization kit components are configured in a Polyester Terephthalate (PET) tray and sealed with a Tyvek lid stock, and sterilized.
Ask a Question
K Number
K014140Device Name
RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET
Manufacturer
SUNDER BIOMEDICAL TECH. CO., LTD.
Date Cleared
2002-11-18
(336 days)
Product Code
FJK
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
SUNDER BIOMEDICAL TECH. CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RENAX (SUNDER) HEMODIALYSIS BLOOD TUBING SET (model: SD-K01, SD-G01) is intended to serve as a conduit through which blood is taken from the patient, delivered to the hemodialyzer, and returned to the patient during hemodialysis therapy. The device is intended to be used for patients suffering from renal disease only.
Device Description
Not Found
Ask a Question
K Number
K003123Device Name
RENAX A.V. FISTULA NEEDLE SETS
Manufacturer
SUNDER BIOMEDICAL TECH. CO., LTD.
Date Cleared
2001-05-04
(211 days)
Product Code
FIE
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
SUNDER BIOMEDICAL TECH. CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1