Radionics Burr Hole Valve
FDA 510(k) K970578 · Radionics, Inc.
510(k) numberK970578
Submission
- Device name
- Radionics Burr Hole Valve
- Applicant
- Radionics, Inc.
Burlington, MA, US - Received
- February 14, 1997
- Decision date
- June 4, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K993594 | Conformax MMLC VR1IYE · Special | 12/15/1999SE |
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Questions and answers
When was Radionics Burr Hole Valve cleared by the FDA?
Radionics Burr Hole Valve (K970578) received a 510(k) decision of Substantially Equivalent on June 4, 1997, 110 days after the submission was received.
What is the product code of K970578?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.