510(k) K953768 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER
| Applicant | Cordis Webster, Inc., Baldwin Park CA, US |
| Decision | Substantially Equivalent, Nov 22, 1995 |
| Received | Aug 14, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953768
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2011 | Biosense Webster, Inc. ISMUS Catheter Mapping Catheter with Auto ID Technology, Manufacturing Part Number D-1171-34-S, Catalog Number D7R20P14CT
The ISMUS Catheter with Auto ID Technology has been designed for electrophysi Terminated |
DRF | None listed |
| Aug 18, 2011 | Biosense Webster, Inc. Duo-Decapolar Electrophysiology Catheter, Manufacturing Part Number D-1171-35-S, Catalog Number D728260RT
Duo-Decapolar Electrophysiology Catheter has been designed for electrophysiological mapping o Terminated |
DRF | None listed |
| Jun 27, 2011 | Biosense Webster, Inc. ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog #
D7R20P14CT
The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac Terminated |
DRF | None listed |
| Jun 27, 2011 | Biosense Webster, Inc. HALO Catheter with Auto 10 Technology, Part Number D-1160-43-S, Catalog Number
D7T20282CT
The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structure Terminated |
DRF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.