Subdural Evacuating Port System, Model 11-9901
FDA 510(k) K002970 · Medical Designs, LLC
510(k) numberK002970
Submission
- Device name
- Subdural Evacuating Port System, Model 11-9901
- Applicant
- Medical Designs, LLC
Brandon, SD, US - Received
- September 22, 2000
- Decision date
- December 12, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Subdural Evacuating Port System, Model 11-9901 cleared by the FDA?
Subdural Evacuating Port System, Model 11-9901 (K002970) received a 510(k) decision of Substantially Equivalent on December 12, 2000, 81 days after the submission was received.
What is the product code of K002970?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.