VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-7-100-2— 510(k) K082890
Substantially EquivalentVnus Medical Technologies, Inc.
FDA 510(k) clearance K082890 for VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-7-100-2, Substantially Equivalent on 2008-10-15. Applicant: Vnus Medical Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Vnus Medical Technologies, Inc.
- 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
- Special
- Location
- San Jose, CA, US
Recent devices under product code GEI
view allMore clearances from Vnus Medical Technologies, Inc.
view all- K061373 — VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100
- K052003 — VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40)
- K040638 — VNUS RADIOFREQUENCY GENERATOR, MODEL RFG2
- K033547 — VNUS VESSEL AND TISSUE COAGULATION SYSTEM
- K030557 — MODIFICATION TO VNUS CLOSURE SYSTEM
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.