Device class
Class II
Regulation 870.4885
Total clearances
3
2022-12-21 → 2026-03-18
Classification details
Medical specialty
Cardiovascular
Regulation number
870.4885
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
LimFlow, Inc.
|
2 |
1 |
2026-03-18 |
|
Aveera Medical, Inc. |
1 |
0 |
2025-07-03 |
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 |
| 33415 |
CPT
|
— |
Medium
|
CPT for pulmonary valve procedures; valvulotome may be used in cardiac valve interventions |
| 37500 |
CPT
|
— |
Medium
|
CPT for vascular endoscopy; valvulotome is a valve-cutting instrument used in vascular procedures |
Pulse
Most recent 510(k) clearances