XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set
FDA 510(k) K242003 · Aesculap, Inc.
510(k) numberK242003
Submission
- Device name
- XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set
- Applicant
- Aesculap, Inc.
Center Valley, PA, US - Received
- July 9, 2024
- Decision date
- December 16, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set cleared by the FDA?
XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (K242003) received a 510(k) decision of Substantially Equivalent on December 16, 2024, 160 days after the submission was received.
What is the product code of K242003?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.