510(k) K042190 ยท LDF Electrode, Pacemaker, Temporary
MODEL 6416 TEMPORARY PACING LEAD SYSTEM
| Applicant | Medtronic Vascular, Minneapolis MN, US |
| Decision | Substantially Equivalent, Sep 7, 2004 |
| Received | Aug 12, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042190
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2016 | Medtronic Inc., Cardiac Rhythm and Heart Failure Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO.
Product Catalog Numbers:
Five (5) Pack Single Pack
6416-100 6416-1005
6416-140 6416-1405
6416-200 6416-2005
Terminated |
LDF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.