FDA 510(k) Applications Submitted by KCI USA, Inc. (Kinetic Concepts, Inc.)
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K133232 |
10/21/2013 |
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
| K120499 |
02/21/2012 |
ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
| K100657 |
03/08/2010 |
V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
| K141017 |
04/21/2014 |
PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
| K161897 |
07/11/2016 |
PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
| K062227 |
08/02/2006 |
V.A.C. THERAPY SYSTEM |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
| K162790 |
10/04/2016 |
V.A.C.ULTA Negative Pressure Wound Therapy System |
KCI USA, Inc. (Kinetic Concepts, Inc.) |
| K103156 |
10/26/2010 |
V.A.C. VERAFLO CLEANSE DRESSING SYSTEM |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
| K160451 |
02/18/2016 |
V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
| K093526 |
11/16/2009 |
V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
| K121883 |
06/28/2012 |
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
| K102956 |
10/04/2010 |
V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
| K123878 |
12/17/2012 |
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
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