510(k) K163356 ยท QEY Mechanical Thrombolysis Catheter
Pulse* Spray Infusion System, Uni*Fuse Infusion System
| Applicant | AngioDynamics, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, May 30, 2017 |
| Received | Nov 30, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163356
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2024 | Angiodynamics, Inc. PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H78712 Open, Classified |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.