K241042
- 510(k) number
- K241042
- Device name
- SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
- Applicant
- Pressure Products Medical Device Manufacturing, LLC PA · US
- Product code
- DRC — Trocar
- Decision date
- 2024-05-17
- Date received
- 2024-04-17
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K241042.pdf
Official FDA record: K241042
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.