FDA 510(k) Applications Submitted by KCI USA, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K123507 |
11/13/2012 |
KCI NPWT GAUZE DRESSING |
KCI USA, INC. |
| K063590 |
12/01/2006 |
V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423 |
KCI USA, INC. |
| K090489 |
02/25/2009 |
ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026 |
KCI USA, INC. |
| K083357 |
11/13/2008 |
OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510 |
KCI USA, INC. |
| K053627 |
12/29/2005 |
MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING |
KCI USA, INC. |
| DEN180013 |
03/15/2018 |
PREVENA 125 and PREVENA PLUS 125 Therapy Units |
KCI USA, Inc. |
| K180855 |
04/02/2018 |
Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System |
KCI USA, Inc. |
| K181507 |
06/07/2018 |
PREVENA RESTOR(TM) Incision Management System |
KCI USA, Inc. |
| K160487 |
02/22/2016 |
V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System |
KCI USA, Inc. |
| K100821 |
03/23/2010 |
PREVENA INCISION MANAGEMENT SYSTEM |
KCI USA, INC. |
| K111280 |
05/06/2011 |
V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT |
KCI USA, INC. |
| K091585 |
06/02/2009 |
VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100 |
KCI USA, INC. |
| K153199 |
11/02/2015 |
Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack |
KCI USA, INC. |
| K173426 |
11/02/2017 |
PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System |
KCI USA, INC. |
| K063692 |
12/13/2006 |
V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000 |
KCI USA, INC. |
| K063740 |
12/18/2006 |
V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766 |
KCI USA, INC. |
| K150006 |
01/02/2015 |
Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing |
KCI USA, INC. |
| K181505 |
06/07/2018 |
V.A.C. DERMATAC Drape |
KCI USA, Inc. |
| K132741 |
09/03/2013 |
V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
KCI USA, INC. |
| K133276 |
10/24/2013 |
V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS |
KCI USA, INC. |
| K173447 |
11/06/2017 |
V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit |
KCI USA, Inc. |
| K190697 |
03/18/2019 |
PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag) |
KCI USA, Inc. |
| K120033 |
01/04/2012 |
ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT |
KCI USA, INC. |
| K183543 |
12/20/2018 |
ACTIV.A.C. Therapy Unit |
KCI USA, Inc. |
| K063426 |
11/13/2006 |
V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10 |
KCI USA, INC. |
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