510(k) K191840
K191840 is an FDA 510(k) premarket notification submitted by Shockwave Medical, Inc. for the device "Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)". The FDA issued a decision of Substantially Equivalent on August 7, 2019. 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
- August 7, 2019
- Date Received
- July 9, 2019
- 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.