510(k) K092789 ยท GCJ Laparoscope, General & Plastic Surgery
VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
| Applicant | Terumo Cardiovascular Systems Corp., Ann Arbor MI, US |
| Decision | Substantially Equivalent, May 12, 2010 |
| Received | Sep 10, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092789
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 21, 2014 | Terumo Cardiovascular Systems Corporation VirtuoSaph Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only***
Product Usage:
The VirtuoSaph Plus Endoscopic Vessel Harvesting System is indicated for use in minimall Terminated |
GCJ | None listed |
| Jul 21, 2011 | Terumo Cardiovascular Systems Corporation VirtuoSaph Plus Endoscopic Vessel Harvesting System , REF VSP550, Sterile, Terumo Cardiovascular System
Indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.