510(k) K992912 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH
| Applicant | Cardiac Pathways Corp., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Mar 8, 2000 |
| Received | Aug 30, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992912
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2005 | Boston Scientific Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (RPM) System, Catalog/Model Numbers: 8300 Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.