510(k) K260044
K260044 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "Ventricular Catheters, Thomale Catheter". The FDA issued a decision of Substantially Equivalent on Oct 2, 2026. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Aesculap, Inc. has 218 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 2, 2026
- Date Received
- Jan 7, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Shunt, Central Nervous System And Components
- Device Class
- Class II
- Regulation Number
- 882.5550
- Review Panel
- NE
- Submission Type
- 510(k)