510(k) K083194 ยท GCJ Laparoscope, General & Plastic Surgery
VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550
| Applicant | Terumo Cardiovascular Systems Corp., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Jan 16, 2009 |
| Received | Oct 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083194
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2011 | Terumo Cardiovascular Systems Corporation Bipolar cord for use with the VirtuoSaph Endoscopic Vein Harvesting System, MCBICORD1, Terumo Cardiovascular System, Ann Arbor, MI.
The Terumo Bipolar cord MCBICORD1 is a flexible, reusable power cabl Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.