K241708
- 510(k) number
- K241708
- Device name
- Abiomed 14Fr Low Profile Introducer Kit
- Applicant
- Abiomed, Inc. MA · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2024-08-06
- Date received
- 2024-06-13
- 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: K241708.pdf
Official FDA record: K241708
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.