Device class
Class II
Regulation 870.4100
Total clearances
8
2021-03-26 → 2025-05-20
Definition
What is Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
A blood pump for long-term circulatory support is a device intended for use as part of an extracorporeal circuit intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
Classification details
Medical specialty
Cardiovascular
Regulation number
870.4100
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Cardiacassist, Inc.
|
3 |
0 |
2024-01-19 |
|
Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) |
2 |
0 |
2023-08-25 |
|
ABBOTT MEDICAL
|
1 |
0 |
2024-01-26 |
|
Medtronic, Inc.
|
1 |
0 |
2025-05-20 |
|
Abbott (Formerly Thoratec Corporation) |
1 |
0 |
2022-12-08 |
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 |
| 33945 |
CPT
|
— |
High
|
Insertion of left ventricular assist device (LVAD) for destination therapy |
| 33946 |
CPT
|
— |
High
|
Insertion of implantable heart assist device (ECMO); intra-operative |
| 33949 |
CPT
|
— |
Medium
|
Insertion of implantable heart assist device (ECMO); percutaneous peripheral approach |
Pulse
Most recent 510(k) clearances