K240246
- 510(k) number
- K240246
- Device name
- Accusafe Transseptal Guidewire (GTR31180, GTR31230)
- Applicant
- Synaptic Medical Corporation CA · US
- Product code
- DRC — Trocar
- Decision date
- 2024-07-26
- Date received
- 2024-01-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K240246.pdf
Official FDA record: K240246
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.