|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
3m™ activ.a.c.™ canister - 300ml with gel (m8275058/5, m8275058/10)
|
KCI USA, Inc.
|
K241134 |
05/23/2024
|
activ.a.c. therapy unit
|
KCI USA, Inc.
|
K183543 |
03/20/2019
|
activac therapy unit and infovac therapy unit, vac ats therapy unit and vac freedom therapy unit, vac via therapy unit
|
KCI USA, INC.
|
K120033 |
05/31/2012
|
kci npwt gauze dressing
|
KCI USA, INC.
|
K123507 |
04/04/2013
|
modification to: v.a.c. granufoam silver protection dressing
|
KCI USA, INC.
|
K053627 |
02/06/2006
|
open abdomen negative pressure therapy system, model 370502, canister, model 370510
|
KCI USA, INC.
|
K083357 |
03/04/2009
|
prevena incision management system
|
KCI USA, INC.
|
K100821 |
06/11/2010
|
prevena incision management system with peel & place dressing, prevena incision management system with customizable dressing
|
KCI USA, INC.
|
K150006 |
11/06/2015
|
prevena plus incision management system (no ag); prevena plus duo incision management system (no ag)
|
KCI USA, Inc.
|
K190697 |
11/22/2019
|
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.
|
K153199 |
02/29/2016
|
|