K242376
- 510(k) number
- K242376
- Device name
- Next Generation Access Platform
- Applicant
- Balt USA, LLC CA · US
- Product code
- QJP — Catheter, Percutaneous, Neurovasculature
- Decision date
- 2024-12-30
- Date received
- 2024-08-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K242376.pdf
Official FDA record: K242376
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.