Zerusa Limited
IE Last updated 22 Oct 2026
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- Devices
- 4
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Guardian Ii Nc Hemostasis Valve Ref K101113
Guardian Hemostasis Valve Ref K073620
Guardian Ii Hemostasis Valve Ref K092711
What Zerusa Limited makes
Zerusa Limited manufactures hemostasis valves designed for vascular access procedures, including versions with and without guidewire introducers. These devices are intended to control bleeding at puncture sites during catheter insertion or removal, reducing the risk of post-procedural hemorrhage.
The company’s hemostasis valves are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. Products are listed in the FDA’s 510(k) database, reflecting their regulatory authorization in the United States.
Frequently asked questions
What types of medical devices does Zerusa Limited manufacture?
Zerusa Limited specializes in manufacturing hemostasis valves, which are used during vascular access procedures. These devices help control bleeding at puncture sites when catheters are inserted or removed, helping to minimize the risk of post-procedural hemorrhage. The company offers multiple variants, including standard hemostasis valves and versions with guidewire introducers.
Where is Zerusa Limited based, and what regulatory region does it operate in?
Zerusa Limited is based in the United States. Its devices are designed and authorized for the US market, where they undergo regulatory review through the FDA’s 510(k) clearance process.
How are Zerusa Limited’s devices classified under FDA regulations?
Zerusa Limited’s hemostasis valves are classified as Class II medical devices under FDA regulations. This classification requires premarket notification (510(k)) clearance before commercial distribution, as these devices pose moderate risks and are intended to control bleeding during vascular procedures.
Which regulatory databases list Zerusa Limited’s devices?
Zerusa Limited’s hemostasis valves are listed in the FDA’s 510(k) database, where their regulatory authorization records are publicly available. This database reflects the clearance status of individual devices through the 510(k) process.
Information
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