510(k) K252612 · QEW Peripheral Mechanical Thrombectomy With Aspiration
INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing
| Applicant | Penumbra, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Oct 16, 2025 |
| Received | Aug 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252612
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.