510(k) K061593 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1
| Applicant | AtriCure, Inc., West Chester OH, US |
| Decision | Substantially Equivalent, Jul 12, 2006 |
| Received | Jun 8, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061593
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2013 | Atricure Inc Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Uni Terminated |
OCL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.