510(k) DEN250046 · SIW Robotic Peripheral Venous Blood Collection System
Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US)
| Applicant | Vitestro, Utrecht, NL |
| Decision | Unknown, Aug 19, 2026 |
| Received | Sep 26, 2025 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN250046
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.