510(k) K101326 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
NMI IC
| Applicant | Navilyst Medical, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Sep 2, 2010 |
| Received | May 11, 2010 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K101326
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.