510(k) K101368 ยท FPA Set, Administration, Intravascular
D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES
| Applicant | Dragon Heart Medical, Inc., Bensenville IL, US |
| Decision | Substantially Equivalent, Nov 18, 2010 |
| Received | May 17, 2010 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K101368
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.