Device class
Class II
Regulation 870.1290
Total clearances
4
2020-12-11 → 2025-11-06
Classification details
Medical specialty
Cardiovascular
Regulation number
870.1290
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Corindus, Inc. |
2 |
0 |
2022-07-27 |
|
Microbot Medical , Ltd. |
1 |
1 |
2025-09-04 |
|
Stereotaxis, Inc.
|
1 |
1 |
2025-11-06 |
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 |
| 93580 |
CPT
|
— |
Medium
|
Steerable catheter control systems are used for percutaneous transseptal procedures |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
| 2025-11-06 |
K251792 |
Stereotaxis, Inc.
|
Stereotaxis GenesisX RMN with Navigant Workstation (NWS) |
| 2025-09-04 |
K243789 |
Microbot Medical , Ltd.
|
LIBERTY Endovascular Robotic System (LIBERTYOS) |
| 2022-07-27 |
K221464 |
Corindus, Inc.
|
CorPath GRX System |
| 2020-12-11 |
K202275 |
Corindus, Inc.
|
CorPath GRX System |