Device class
—
Regulation —
Total clearances
4
2022-11-23 → 2025-11-21
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Ultromics Limited
|
2 |
0 |
2024-09-23 |
|
Icardio.Ai |
1 |
1 |
2025-11-21 |
|
Avicena, LLC |
1 |
0 |
2023-10-06 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 93285 |
CPT
|
— |
Medium
|
CPT for programming of implantable hemodynamic monitor; heart failure status assessment |
| 99457 |
CPT
|
— |
Medium
|
CPT for remote therapeutic monitoring; adjunctive heart failure monitoring/evaluation |
Pulse
Most recent 510(k) clearances