VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
FDA 510(k) clearance K092789 · decided 2010-05-12
Clearance details
- K-number
- K092789
- Device name
- VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
- Applicant
- Terumo Cardiovascular Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2009-09-10
- Decision date
- 2010-05-12
- Days to decision
- 244 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Ann Arbor, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VirtuoSaph Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Onl recall (Z-1069-2014) | Terumo Cardiovascular Systems Corporation | 2014-02-21 |
| VirtuoSaph Plus Endoscopic Vessel Harvesting System , REF VSP550, Sterile, Terumo Cardiova recall (Z-2854-2011) | Terumo Cardiovascular Systems Corporation | 2011-07-21 |