VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM— 510(k) K140008
Substantially EquivalentTerumo Cardiovascular Systems Corporation
FDA 510(k) clearance K140008 for VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM, Substantially Equivalent on 2014-10-31. Applicant: Terumo Cardiovascular Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Terumo Cardiovascular Systems Corporation
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkton, MD, US
Recent devices under product code GEI
view allMore clearances from Terumo Cardiovascular Systems Corporation
view all- K234065 — CDI OneView Monitoring System
- K221895 — Terumo Advanced Perfusion System 1
- K200091 — Capiox iCP Centrifugal Pump
- K182110 — CDI Blood Parameter Monitoring System 550
- K180950 — Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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 →
Recalls naming K140008
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140008.
Data sourced from openFDA. This site is unofficial and independent of the FDA.