510(k) K140318 ยท OBJ Catheter, Ultrasound, Intravascular
SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER
| Applicant | Biosense Webster, Diamond Bar CA, US |
| Decision | Substantially Equivalent, Mar 12, 2014 |
| Received | Feb 10, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140318
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2015 | Biosense Webster, Inc. SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other device Terminated |
OBJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.