K243757 is an FDA 510(k) clearance for the Shockwave CS Guide Catheter. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Shockwave Medical, Inc. (Santa Clara, US). The FDA issued a Cleared decision on May 2, 2025, 147 days after receiving the submission on December 6, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K243757 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2024 |
| Decision Date | May 02, 2025 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY - Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |