510(k) K221339 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection
| Applicant | Contego Medical, Inc., Raleigh NC, US |
| Decision | Substantially Equivalent, Jun 9, 2022 |
| Received | May 9, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K221339
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.