510(k) K262201
K262201 is an FDA 510(k) premarket notification submitted by Shockwave Medical, Inc. for the device "Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter". The FDA issued a decision of Substantially Equivalent on Jul 27, 2026. The device falls under product code PPN (Percutaneous Catheter, Ultrasound), a Class II device regulated under 21 CFR 870.1250. Shockwave Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 27, 2026
- Date Received
- Jun 29, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Percutaneous Catheter, Ultrasound
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.