Device class
Class II
Regulation 870.4250
Total clearances
3
2020-02-25 → 2022-11-16
Definition
What is Controller, Temperature, Cardiopulmonary Bypass
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification details
Medical specialty
Cardiovascular
Regulation number
870.4250
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
|
Temperature controller for cardiopulmonary bypass circuit management |
| 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 controller supply code |
Pulse
Most recent 510(k) clearances