510(k) K081049 ยท DRA Catheter, Steerable
FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12
| Applicant | Cryocath Technologies, Inc., Galisteo NM, US |
| Decision | Substantially Equivalent, Jun 27, 2008 |
| Received | Apr 14, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081049
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.