510(k) K260459 ยท DYB Introducer, Catheter
VANES Delivery System (VDS)
| Applicant | Zoll Respicardia, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Apr 6, 2026 |
| Received | Feb 11, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260459
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.