510(k) K103746 ยท DQK Computer, Diagnostic, Programmable
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)
| Applicant | Biosense Webster, Inc., Diamond Bar CA, US |
| Decision | Substantially Equivalent, Jan 21, 2011 |
| Received | Dec 23, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103746
| 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.