K252309
- 510(k) number
- K252309
- Device name
- PerQseal Introducers
- Applicant
- Vivasure Medical Limited IE
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2025-10-23
- Date received
- 2025-07-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252309.pdf
Official FDA record: K252309
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.