510(k) K003452 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D
| Applicant | Ep Technologies, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Dec 7, 2000 |
| Received | Nov 7, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K003452
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.