Codman VPV System, Model 82-3192
FDA 510(k) K050739 · Codman & Shurtleff, Inc.
510(k) numberK050739
Submission
- Device name
- Codman VPV System, Model 82-3192
- Applicant
- Codman & Shurtleff, Inc.
Raynham, MA, US - Received
- March 21, 2005
- Decision date
- July 18, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Codman VPV System, Model 82-3192 cleared by the FDA?
Codman VPV System, Model 82-3192 (K050739) received a 510(k) decision of Substantially Equivalent on July 18, 2005, 119 days after the submission was received.
What is the product code of K050739?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.