510(k) K093455 ยท DQK Computer, Diagnostic, Programmable
CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES
| Applicant | Biosense Webster, Inc., Diamond Bar CA, US |
| Decision | Substantially Equivalent, Dec 4, 2009 |
| Received | Nov 5, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093455
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2012 | Biosense Webster, Inc. CARTO 3 Systems, Product Code M-4800-01
The intended use of the CARTO 3 System is catheter-based cardiac electrophysiological (EP) procedures. Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.