K243757
- 510(k) number
- K243757
- Device name
- Shockwave CS Guide Catheter
- Applicant
- Shockwave Medical, Inc. CA · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2025-05-02
- Date received
- 2024-12-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243757.pdf
Official FDA record: K243757
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.