Device class
Class II
Regulation 870.4400
Total clearances
4
2023-06-10 → 2025-12-22
Classification details
Medical specialty
Cardiovascular
Regulation number
870.4400
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 |
| 99166 |
CPT
|
— |
Medium
|
Cardiopulmonary bypass blood reservoir component for ECMO/bypass support |
| C9356 |
HCPCS
|
Tendon, porous matrix of cross-linked collagen and glycosaminoglycan matrix (tenoglide tendon protector sheet), per square centimeter ✓ CMS-verified description |
Low
|
Bypass circuit component supply code |
Pulse
Most recent 510(k) clearances