510(k) K112292 ยท NLH Catheter, Recording, Electrode, Reprocessed
REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER
| Applicant | Stryker Sustainability Solutions, Tempe AZ, US |
| Decision | Substantially Equivalent, Oct 21, 2011 |
| Received | Aug 10, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112292
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2024 | Stryker Sustainability Solutions Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only Open, Classified |
NLH | None listed |
| Dec 17, 2018 | Stryker Sustainability Solutions BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301
Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be Terminated |
NLH | None listed |
| Aug 23, 2018 | Stryker Sustainability Solutions Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart. Terminated |
NLH | None listed |
| Jan 2, 2018 | Stryker Sustainability Solutions Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx.
The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters Terminated |
NLH | None listed |
| Jan 2, 2018 | Stryker Sustainability Solutions Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134302, Sterile, Rx.
The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters Terminated |
NLH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.