FDA 510(k) Applications Submitted by Sam Nanavati
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150046 |
01/12/2015 |
Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter |
Zoll Circulation, Inc. |
| K030557 |
02/21/2003 |
MODIFICATION TO VNUS CLOSURE SYSTEM |
VNUS MEDICAL TECHNOLOGIES, INC. |
| K040638 |
03/10/2004 |
VNUS RADIOFREQUENCY GENERATOR, MODEL RFG2 |
VNUS MEDICAL TECHNOLOGIES, INC. |
| K101987 |
07/14/2010 |
COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 |
ZOLL CIRCULATION |
| K052003 |
07/25/2005 |
VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40) |
VNUS MEDICAL TECHNOLOGIES, INC. |
| K003092 |
10/03/2000 |
MODIFICATION TO VNUS CLOSURE SYSTEM |
VNUS MEDICAL TECHNOLOGIES, INC. |
| K112998 |
10/07/2011 |
AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 |
ZOLL CIRCULATION |
| K153226 |
11/06/2015 |
Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit |
ZOLL CIRCULATION, INC. |
| K033547 |
11/12/2003 |
VNUS VESSEL AND TISSUE COAGULATION SYSTEM |
VNUS MEDICAL TECHNOLOGIES, INC. |
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