K252766
- 510(k) number
- K252766
- Device name
- 14Fr Low Profile Introducer Kit
- Applicant
- Abiomed, Inc. MA · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2025-10-08
- Date received
- 2025-08-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K252766.pdf
Official FDA record: K252766
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.