VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550
FDA 510(k) clearance K083194 · decided 2009-01-16
Clearance details
- K-number
- K083194
- Device name
- VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550
- Applicant
- Terumo Cardiovascular Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2008-10-29
- Decision date
- 2009-01-16
- Days to decision
- 79 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 |
|---|---|---|
| Bipolar cord for use with the VirtuoSaph Endoscopic Vein Harvesting System, MCBICORD1, Ter recall (Z-1230-2011) | Terumo Cardiovascular Systems Corporation | 2011-02-14 |