K243954
- 510(k) number
- K243954
- Device name
- PeriCross Epicardial Access Kit
- Applicant
- Circa Scientific, Inc. CO · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2025-04-24
- Date received
- 2024-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243954.pdf
Official FDA record: K243954
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.