K240589
- 510(k) number
- K240589
- Device name
- Micropuncture Introducer Sets; Micropuncture Pedal Access Sets
- Applicant
- Cook Medical IN · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2024-03-25
- Date received
- 2024-03-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K240589.pdf
Official FDA record: K240589
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.