K261242
- 510(k) number
- K261242
- Device name
- SimplGuide
- Applicant
- Pendracare NL
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2026-06-25
- Date received
- 2026-04-15
- 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: K261242.pdf
Official FDA record: K261242
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.