K250972
- 510(k) number
- K250972
- Device name
- Primum Hydrophilic Guiding Catheter
- Applicant
- Pendracare NL
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2025-06-29
- Date received
- 2025-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K250972.pdf
Official FDA record: K250972
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.