510(k) K113622 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
ORION II CT CVC
| Applicant | Health Line International Corporation (Hlic), Centerville UT, US |
| Decision | Substantially Equivalent, May 18, 2012 |
| Received | Dec 8, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113622
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.