510(k) clearance
Ventricular Catheters, Thomale Catheter
- 510(k) number
- K260044
- Applicant
- Aesculap, Inc.
- Decision date
- Oct 2, 2026
- Date received
- Jan 7, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- JXG
- Device type
- Shunt, Central Nervous System And Components
- Device class
- Class II
- Regulation
- 21 CFR 882.5550
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Center Valley, PA, US