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510(k) Data Aggregation
K Number
K241581Device Name
Hemodialysis Catheter
Manufacturer
Haolang Medical USA Corporation
Date Cleared
2025-05-16
(347 days)
Product Code
MSD
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
Haolang Medical USA Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- The Hemodialysis Catheter is indicated for use in attaining short-term or long-term vascular access for Hemodialysis therapy and apheresis.
* It may be inserted percutaneously and is primarily placed in the internal jugular vein of an patient.
* Alternate insertion sites include subclavian vein as required.
* Catheters greater than 40 cm are intended for femoral vein insertion.
* The curved Hemodialysis Catheter is intended for internal jugular vein insertion.
* 8-10Fr Hemodialysis Catheters can be used in pediatric patients.
Device Description
The Hemodialysis Catheter is indicated for use in attaining vascular access for Hemodialysis and Apheresis therapy. The catheter tubing is made of radiopaque polyurethane with a dual D cross-sectional design, providing independent arterial and venous lumens. The proximal end of the catheter features two luer connectors. The luer connectors are connected to extension legs. The extension legs are made of silicone material. Each extension leg has a catheter clamp, which is durable and can effectively ensure timely closure of the extension leg. The lumen with the red catheter clamp, which is called arterial lumen, is used for blood outflow; The lumen with the blue catheter clamp, which is called venous lumen, is used for blood return. The arterial and venous lumen priming volumes are printed directly on the ID ring of the clamp. Catheters range from approximately 13-55 cm long and are offered in straight or curved catheter configurations with cuff for long-term implantation. The Hemodialysis Catheter is packaged in a tray with legally marketed accessories intended for use during catheter placement. The Hemodialysis Catheter Kit is provided sterile, single use.
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K Number
K201726Device Name
Arterial Catheter
Manufacturer
Haolang Medical USA Corporation
Date Cleared
2021-07-07
(379 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Haolang Medical USA Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Arterial Catheter permits access to the peripheral arterial circulation.
Device Description
The Arterial Catheter is a lumen peripherally inserted catheter assembly designed to perform short term access to the peripheral arterial circulatory system for less than 7 days, it is also intended to be used for pressure monitoring. It consists of an introducer needle or catheter-over-needle assembly, spring guide wire, and a catheter assembly that incorporates an extension tubing segment with a slide clamp and a flex tube end cap. These components are used together for catheter insertion using the "Seldinger" catheter-over-guide-wire insertion technique, which divided into three types according to structure: Standard Seedinger; Modified Seedinger-Integrated; Modified Seedinger-Sleeve. The Arterial Catheter is available in 18 ga, 20 ga, 21 ga, 22 ga and 24 ga, the corresponding diameter of guide wire is 0.025", 0.018", 0.015", 0.012". Configurations with usable lengths of 2.5 cm to 23 cm. The catheters are attached to an injection molded polyurethane hub with Luer lock fittings for access attachment. The Arterial Catheter is provided sterile.
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K Number
K201697Device Name
Umbilical Vessels Catheter
Manufacturer
Haolang Medical USA Corporation
Date Cleared
2021-05-06
(318 days)
Product Code
FOS
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Haolang Medical USA Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
UMBILICAL VESSELS CATHETER is intended for short-term vascular access via umbilical vessels in neonatal patients:
Via the umbilical artery:
--- sampling of blood,
---measurement of intravascular arterial pressure.
Via the umbilical vein:
--- infusion (simultaneous infusion of several medicinal products for the dual lumen catheter).
Device Description
The UMBILICAL VESSELS CATHETER has catheters in single lumen and dual lumen. The catheters tube is made of radiopaque polyurethane which is insert molded to a polyurethane hub. The insertion tip of the catheter has been heat melted to form a smooth, rounded tip to reduce tissue trauma upon insertion.
Placement of the device is facilitated by depth markings, which are printed on the catheter at 1 cm intervals, beginning at 5 cm from the insertion tip and continuing to 40 cm from the tip. Catheter placement must be confirmed by x-ray.
The UMBILICAL VESSELS CATHETER has 17 primary configurations: Catheters in 2 Fr., 2.5 Fr., 2.8 Fr., 3 Fr., 3.5 Fr., 4 Fr., 5 Fr., 6 Fr., 6.5 Fr. and 7 Fr. for Single lumen; 2.8 Fr., 3 Fr., 3.5 Fr., 4 Fr., 5 Fr., 6 Fr. and 6.5 Fr. for dual lumen. Each device will continue to be packaged in a Tyvek pouches are packaged in a carton. The UMBILICAL VESSELS CATHETER does not contain DEHP and is Ethylene Oxide sterilized. The product and packaging are not made of natural rubber latex.
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