Device class
Class II
Regulation 870.1250
Total clearances
9
2021-04-22 → 2026-08-24
Definition
What is Percutaneous Catheter, Ultrasound
Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.
Classification details
Medical specialty
Cardiovascular
Regulation number
870.1250
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 |
| 92998 |
CPT
|
— |
Medium
|
Percutaneous transluminal angioplasty with ultrasound guidance |
| C1730 |
HCPCS
|
Catheter, electrophysiology, diagnostic, other than 3d mapping (19 or fewer electrodes) ✓ CMS-verified description |
Medium
|
Catheter, transluminal angioplasty, non-laser |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-08-24 |
K260246 |
Bolt Medical, Inc.
|
SEISMIQ Intravascular Lithotripsy System |
| 2026-07-27 |
K262201 |
Shockwave Medical, Inc.
|
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter |
| 2025-03-25 |
K250225 |
Bolt Medical, Inc.
|
Bolt Intravascular Lithotripsy (IVL) System |
| 2024-09-27 |
K242213 |
Shockwave Medical, Inc.
|
Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter |
| 2024-05-07 |
K240954 |
Shockwave Medical, Inc.
|
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter |
| 2024-03-22 |
K240225 |
Shockwave Medical, Inc.
|
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter |
| 2022-08-16 |
K221852 |
Shockwave Medical, Inc.
|
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter |
| 2022-04-25 |
K221041 |
Shockwave Medical, Inc.
|
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System |
| 2021-04-22 |
K203365 |
Shockwave Medical, Inc.
|
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter |