Device class
Class II
Regulation 870.4100
Total clearances
3
2022-01-14 → 2026-01-15
Definition
What is Single Lumen Ecmo Cannula
Single-lumen cannulas/catheters to be used with an extracorporeal circuit intended for use 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
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 |
| 36821 |
CPT
|
— |
High
|
Arteriovenous cannula insertion; standard for ECMO access and cannulation |
| 36822 |
CPT
|
— |
High
|
Venipuncture; central venous catheter placement for extracorporeal circulation |
| R0076 |
HCPCS
|
Transportation of portable ekg to facility or location, per patient ✓ CMS-verified description |
Medium
|
ECMO procedure; extracorporeal membrane oxygenation service code |
Pulse
Most recent 510(k) clearances