K242169
- 510(k) number
- K242169
- Device name
- Morph DNA Steerable Introducer Sheath
- Applicant
- Biocardia CA · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2024-08-23
- Date received
- 2024-07-24
- 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: K242169.pdf
Official FDA record: K242169
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.