ACUNAV Luxera 4D ICE Catheter— 510(k) K261696
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K261696 for ACUNAV Luxera 4D ICE Catheter, Substantially Equivalent on 2026-09-10. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Summary
The ACUNAV Luxera 4D ICE Catheter is filed under OBJ, intravascular ultrasound catheters. The code covers catheters for intracardiac and intraluminal visualization of cardiovascular anatomy and physiology. The record doesn't define "4D" or "ICE."
Class II, 21 CFR 870.1200. The Cardiovascular panel reviewed it as a Special 510(k).
Siemens Medical Solutions USA filed from Issaquah, Washington. Review took 111 days (May 22 to September 10, 2026).
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Product code OBJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Issaquah, WA, US
Recent devices under product code OBJ
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allAdverse events under product code OBJ
product code OBJ- Death
- 38
- Injury
- 634
- Malfunction
- 3,453
- Total
- 4,125
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.