510(k) K002333 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220
| Applicant | Biosense Webster, Inc., Diamond Bar CA, US |
| Decision | Substantially Equivalent, Aug 31, 2000 |
| Received | Aug 1, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002333
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2011 | Biosense Webster, Inc. LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-122081-
S, Catalog Numbers D7L2020CT
The affected catheters are indicated for multiple electrode electrophysiologic Terminated |
DRF | None listed |
| Jun 27, 2011 | Biosense Webster, Inc. LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-1220-82-S, Catalog Numbers 07L2015CT
The affected catheters are indicated for multiple electrode electrophysiologic Terminated |
DRF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.