Hakim Programmable Valve System
FDA 510(k) K974739 · Johnson & Johnson Professionals, Inc.
510(k) numberK974739
Submission
- Device name
- Hakim Programmable Valve System
- Applicant
- Johnson & Johnson Professionals, Inc.
Raynham, MA, US - Received
- December 19, 1997
- Decision date
- July 1, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K983141 | Capitello-Condylar Total Elbow ProsthesisJDB · Traditional | 11/06/1998SE |
| K983014 | Summit Acetabular SystemLPH · Traditional | 10/27/1998SE |
| K980778 | Hakim Micro Programmable Valve SystemJXG · Traditional | 07/17/1998SE |
| K980801 | J-Fx Bipolar HeadKWY · Traditional | 05/29/1998SE |
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Questions and answers
When was Hakim Programmable Valve System cleared by the FDA?
Hakim Programmable Valve System (K974739) received a 510(k) decision of Substantially Equivalent on July 1, 1998, 194 days after the submission was received.
What is the product code of K974739?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.