Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter— 510(k) K203365
Substantially EquivalentShockwave Medical, Inc.
FDA 510(k) clearance K203365 for Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter, Substantially Equivalent on 2021-04-22. Applicant: Shockwave Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Shockwave Medical, Inc.
- Product code
- Code PPN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
Recent devices under product code PPN
view all- K260246 — SEISMIQ Intravascular Lithotripsy System
- K262201 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
- K250225 — Bolt Intravascular Lithotripsy (IVL) System
- K242213 — Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter
- K240954 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
More clearances from Shockwave Medical, Inc.
view all- K243757 — Shockwave CS Guide Catheter
- K240225 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
- K221852 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
- K221041 — Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
- K191840 — Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)
Adverse events under product code PPN
product code PPN- Death
- 16
- Total
- 16
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.