Ventricular Catheter Set
FDA 510(k) K962097 · Cook, Inc.
510(k) numberK962097
Submission
- Device name
- Ventricular Catheter Set
- Applicant
- Cook, Inc.
Bloomington, IN, US - Received
- May 29, 1996
- Decision date
- August 29, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Ventricular Catheter Set cleared by the FDA?
Ventricular Catheter Set (K962097) received a 510(k) decision of Substantially Equivalent on August 29, 1996, 92 days after the submission was received.
What is the product code of K962097?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.