FDA device listing
Lithoplasty Peripheral Balloon Dilatation Catheter,Shockwave M5 IVL Catheter,Shockwave Medical, Inc. Peripheral…
FDA device listing 1827775169 · Shockwave Medical, Inc.
Key facts
| Proprietary names | Lithoplasty Peripheral Balloon Dilatation Catheter,Shockwave M5 IVL Catheter,Shockwave Medical, Inc. Peripheral Intravascular Lithotripsy (IVL) System,Shockwave Medical, Inc. Peripheral Lithoplasty System,Shockwave S4 IVL Catheter |
|---|---|
| Owner/operator | Shockwave Medical, Inc. |
| Owner/operator number | 10046972 |
| Premarket submissions | K163306 |
| Product codes | PPN |
| Device names | PPN - Percutaneous Catheter, Ultrasound |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1250 |
| Review panels | Cardiovascular |
| Registered establishments | SHOCKWAVE MEDICAL, INC. |
| Establishment registrations | 3015053858 |
| FEI numbers | 3015053858 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database