Chrysalis Intelligence · Product Codes · PPN

PPN · Unclassified

8 clearances · 2 unique sponsors

Device class
Regulation —
Total clearances
8
2021-04-22 → 2026-07-27
Last 12 months
1
Unique sponsors
2
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Shockwave Medical, Inc. 7 1 2026-07-27
Bolt Medical, Inc. 1 0 2025-03-25
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.

CodeTypeDescriptionConfidenceRationale
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

DateK-numberSponsorDevice
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