510(k) K080292 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
EPICOR ABLATION SYSTEM
| Applicant | St Jude Medical, St. Paul MN, US |
| Decision | Substantially Equivalent, Jul 25, 2008 |
| Received | Feb 4, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080292
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 7, 2010 | St. Jude Medical Atrial Fibrillation Division Inc St. Jude Medical Epicor UltraWand LP Handheld Ablation Device, model UW-LP-2, Sterilized with Ethylene Oxide. Single-use. The Ultra Wand LP device is designed for use with the Epicor Cardiac Ablatio Terminated |
OCL | None listed |
| Jan 30, 2009 | St. Jude Medical Inc Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor Cardiac Ablation Control System, manufactured by St.Jude Medical, Sunnyvale, CA
Disposable connecting cable, ac Terminated |
OCL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.