510(k) K040694 ยท HCG Device, Neurovascular Embolization
MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)
| Applicant | Micro Therapeutics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 25, 2004 |
| Received | Mar 17, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040694
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.