510(k) K082074 ยท GEH Unit, Cryosurgical, Accessories
ATRICURE CRYO1 CRYO-ABLATION PROBE
| Applicant | AtriCure, Inc., West Chester OH, US |
| Decision | Substantially Equivalent, Mar 2, 2009 |
| Received | Jul 23, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082074
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 30, 2014 | Atricure Inc Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches
Product Usage:
Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single u Terminated |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.