510(k) K012926 ยท MTD Catheter, Intracardiac Mapping, High-Density Array
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
| Applicant | Endocardial Solutions, Inc., St. Paul MN, US |
| Decision | Unknown, Sep 28, 2001 |
| Received | Aug 31, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012926
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.