VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550— 510(k) K083194
Substantially EquivalentTerumo Cardiovascular Systems Corp.
FDA 510(k) clearance K083194 for VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550, Substantially Equivalent on 2009-01-16. Applicant: Terumo Cardiovascular Systems Corp.. Device class: 2.
Clearance details
- Applicant
- Terumo Cardiovascular Systems Corp.
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
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More clearances from Terumo Cardiovascular Systems Corp.
view all- K153140 — Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating
- K133658 — CDI BLOOD PARAMETER MONITORING SYSTEM 500
- K131041 — ADVANCED PERFUSION SYSTEM 1
- K132451 — SARNS SOFT-FLOW AORTIC CANNULA
- K133151 — SARNS HIGH FLOW AORTIC ARCH CANNULA
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.