Vnus Medical Technologies, Inc.
Sunnyvale, CA, US
Vnus Medical Technologies, Inc. appears in FDA device records in Sunnyvale, CA. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Vnus Medical Technologies, Inc. between 1998 and 2008. The busiest year on record is 2004, with 2. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 1 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 1 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K082890 | VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-7-100-2 | GEI | Substantially Equivalent | |
| K061373 | VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100 | GEI | Substantially Equivalent | |
| K052003 | VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40) | GEI | Substantially Equivalent | |
| K040638 | VNUS RADIOFREQUENCY GENERATOR, MODEL RFG2 | GEI | Substantially Equivalent | |
| K033547 | VNUS VESSEL AND TISSUE COAGULATION SYSTEM | GEI | Substantially Equivalent | |
| K030557 | MODIFICATION TO VNUS CLOSURE SYSTEM | GEI | Substantially Equivalent | |
| K003092 | MODIFICATION TO VNUS CLOSURE SYSTEM | GEI | Substantially Equivalent | |
| K982816 | VNUS CLOSURE SYSTEM | GEI | Substantially Equivalent | |
| K974521 | VNUS CLOSURE SYSTEM | GEI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0543-2008 | VNUS 7F ClosureFAST Catheter, Order # ClF7-7-100 (100 cm working length), Manufactured by VNUS Medical Technologies, Inc., 5799 Fontanoso Way, San Jose, CA 95138 | Instructions for Use change: Instructions for Use have been changed to include a modified placement recommendation. | Terminated | ||
| Z-0542-2008 | VNUS 7F ClosureFAST Catheter, Order #: CF7-7-60 (60 cm working length), Manufactured by VNUS Medical Technologies, Inc., 5799 Fontanoso Way, San Jose, CA 95138 | Instructions for Use change: Instructions for Use have been changed to include a modified placement recommendation. | Terminated | ||
| Z-0132-2008 | VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San Jose, CA 95138 | Sterility (package integrity) Compromised: Product sterility may be compromised due to a pinhole under the pouch foldover. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain