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Kci USA, Inc.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories1
Latest FDA decision2024-05-23
TypeNumberDevice NameCodeDateActions
510(k) K241134 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)OMP2024-05-23 View
510(k) K201571 ACTIV.A.C. Negative Pressure Wound Therapy SystemOMP2020-07-08 View
510(k) K200390 V.A.C. DERMATAC DrapeOMP2020-05-18 View
510(k) K190697 PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)OMP2019-11-22 View
510(k) K181505 V.A.C. DERMATAC DrapeOMP2019-03-28 View
510(k) K183543 ACTIV.A.C. Therapy UnitOMP2019-03-20 View
510(k) K181507 PREVENA RESTOR(TM) Incision Management SystemOMP2019-02-15 View
510(k) K180855 Prevena Plus Incision Management System, Prevena Plus Duo Incision Management SystemOMP2018-06-01 View
510(k) K173426 PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management SystemOMP2018-03-09 View
510(k) K173447 V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy UnitOMP2018-03-02 View
510(k) K160487 V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemOMP2016-12-09 View
510(k) K153199 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-PackOMP2016-02-29 View
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