510(k) K221041
K221041 is an FDA 510(k) premarket notification submitted by Shockwave Medical, Inc. for the device "Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System". The FDA issued a decision of Substantially Equivalent on April 25, 2022. 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
- April 25, 2022
- Date Received
- April 8, 2022
- 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.