510(k) K181128 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)
| Applicant | Contego Medical, LLC, Raleigh NC, US |
| Decision | Substantially Equivalent, Sep 6, 2018 |
| Received | Apr 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181128
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.