510(k) clearance
ACUNAV Luxera 4D ICE Catheter
- 510(k) number
- K261696
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision date
- Sep 10, 2026
- Date received
- May 22, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- OBJ
- Device type
- Catheter, Ultrasound, Intravascular
- Device class
- Class II
- Regulation
- 21 CFR 870.1200
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Issaquah, WA, US