Device class
Class II
Regulation 870.4380
Total clearances
5
2020-03-06 → 2024-05-24
Classification details
Medical specialty
Cardiovascular
Regulation number
870.4380
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Apmtd, Inc. |
2 |
0 |
2023-04-18 |
|
Inspira Technologies Oxy B.H.N. , Ltd. |
1 |
0 |
2024-05-24 |
|
Spectrum Medical , Ltd.
|
1 |
0 |
2020-04-13 |
|
Abbott (Formerly Thoratec Corporation) |
1 |
0 |
2020-03-06 |
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
|
Pump speed controller component of cardiopulmonary bypass 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 equipment controller supply |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2024-05-24 |
K232788 |
Inspira Technologies Oxy B.H.N. , Ltd.
|
INSPIRA ART100 |
| 2023-04-18 |
K230698 |
Apmtd, Inc.
|
Anivia SG1000 Pump Console |
| 2023-02-03 |
K221491 |
Apmtd, Inc.
|
Anivia SG1000 Pump Console |
| 2020-04-13 |
K192838 |
Spectrum Medical , Ltd.
|
Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure |
| 2020-03-06 |
K200306 |
Abbott (Formerly Thoratec Corporation)
|
CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit |