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510(k) Data Aggregation
K Number
K102833Device Name
DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS
Manufacturer
FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD
Date Cleared
2011-11-18
(415 days)
Product Code
MPB
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable Hemodialysis Access Catheter Sets, including Single-lumen and Dual-lumen, are intended to attain long or short term (less than 30 days) vascular access for hemodialysis via the internal jugular, subclavian or femoral vein.
Device Description
Disposable Hemodialysis Access Catheter Sets, including Single-lumen and Dual-lumen, are intended to attain long or short term (less than 30 days) vascular access for hemodialysis via the internal jugular, subclavian or femoral vein. It consists of a catheter, a puncture needle, a guide wire and a dilator. The set is provided EO sterilized.
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K Number
K070451Device Name
ABLE CENTRAL VENOUS CATHETER
Manufacturer
FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD
Date Cleared
2007-07-31
(166 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Central Venous Catheters including:
14 G, 16 G, 18 G, and 20 G in single-lumen catheters;
4 F. 5 F, 7 F and 8 F in double-lumen catheter;
5.5 F and 7 F in triple-lumen catheter;
are intended for vascular access infusion and withdrawal of blood, blood products, and fluids, plasma pheresis, hyperalimentation, central venous blood sampling and continuous and intermittent drug infusion.
Device Description
Able® Central Venous Catheter is a polyurethane central venous catheter which is intended to insert into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously.
All the variants of applicant devices: single-lumen, and triple-lumen, and triple-lumen. There are outer diameter dimensions of 14 G, 16 G, 18 G, and 20 G in single-lumen catheters, 4 F, 5 F, 7 F and 8 F in double-lumen catheter, and 5.5 F and 7 F in triple-lumen catheter.
The applicant device mainly consists of 5 parts: distal end, catheter body of effective length, catheter junction, extension cannula, and catheter hub. Distal end is soft and flexible, which is intended to be located within the patient's vena cava. Catheter body of effective length is tubular and with no-communication single or multiple lumens. Catheter junction attaches catheter body of effective length and extension cannula. At the end of the extension cannula, there is female catheter hub for the connection.
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