FDA Device Establishments · JSON-LD · Markdown
FEI 3015053858 · Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3015053858 |
|---|---|
| Owner / Operator | Shockwave Medical, Inc. (#10046972) |
| Address | 5403 Betsy Ross Drive, Santa Clara, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | PPN |
| Regulation § (21 CFR) | 870.1250 |
| Proprietary names | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter |
Source: openFDA. Public-domain (CC0).