Device class
Class II
Regulation 870.4330
Total clearances
3
2020-10-02 → 2024-04-25
Classification details
Medical specialty
Cardiovascular
Regulation number
870.4330
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
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 |
| 82803 |
CPT
|
— |
Medium
|
Blood gas analysis CPT code; on-line monitoring during cardiopulmonary bypass |
| 99211 |
CPT
|
— |
Low
|
Monitoring service code; context-dependent on intraoperative use |
Pulse
Most recent 510(k) clearances