V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000

Negative Pressure Wound Therapy Powered Suction Pump

KCI USA, INC.

The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for V.a.c. Therapy Systems-acti V.a.c. Therapy Unit Model# 340000.

Pre-market Notification Details

• Device ID: K063692
• 510k Number: K063692
• Device Name: V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000
• Classification: Negative Pressure Wound Therapy Powered Suction Pump
• Applicant: KCI USA, INC. 8023 VANTAGE DR. San Antonio, TX 78230 -4726
• Contact: Margaret Marsh
• Correspondent: Margaret Marsh; KCI USA, INC. 8023 VANTAGE DR. San Antonio, TX 78230 -4726
• Product Code: OMP
• CFR Regulation Number: 878.4780 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-12-13
• Decision Date: 2007-06-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00878237008188	K063692	000
00878237001486	K063692	000
00849554005600	K063692	000
00849554001992	K063692	000