510(k) K161765 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
CG+ Arrow JACC
| Applicant | Arrow International, Inc. (Subsidiary of Teleflex, Reading PA, US |
| Decision | Substantially Equivalent, Sep 6, 2016 |
| Received | Jun 27, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161765
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.