510(k) K012520 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E
| Applicant | Cardiac Assist Devices, Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Mar 27, 2002 |
| Received | Aug 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012520
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.