510(k) K123837 ยท MTD Catheter, Intracardiac Mapping, High-Density Array
PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
| Applicant | Biosense Webster, Inc., Diamond Bar CA, US |
| Decision | Substantially Equivalent, Mar 5, 2013 |
| Received | Dec 13, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123837
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2020 | BIOSENSE WEBSTER PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electr Terminated |
MDT | None listed |
| May 17, 2017 | Biosense Webster, Inc. PENTARAY NAV High-Density Mapping Catheter. Terminated |
MTD | None listed |
| May 17, 2017 | Biosense Webster, Inc. PENTARAY NAV High-Density Mapping Catheter. Terminated |
MTD | None listed |
| Apr 14, 2016 | Biosense Webster, Inc. Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212
The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multip Terminated |
MTD | None listed |
| Mar 11, 2014 | Biosense Webster, Inc. PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211.
The Biosense Webster PENTARAY NAV High-De Terminated |
MTD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.