K260459
- 510(k) number
- K260459
- Device name
- VANES Delivery System (VDS)
- Applicant
- Zoll Respicardia, Inc. MN · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2026-04-06
- Date received
- 2026-02-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K260459.pdf
Official FDA record: K260459
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.