FDA 510(k)

V.A.C. THERAPY SYSTEM

K-Number: K062227 · 2006-10-04

ApplicantKci USA, Inc. (Kinetic Concepts, Inc.)

Decision Date2006-10-04

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

V.A.C. THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kci USA, Inc. (Kinetic Concepts, Inc.). It received FDA 510(k) clearance on 2006-10-04 under 510(k) number K062227. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V.A.C. THERAPY SYSTEM?

V.A.C. THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2006-10-04. The listed applicant is Kci USA, Inc. (Kinetic Concepts, Inc.). The 510(k) number is K062227.

When did V.A.C. THERAPY SYSTEM receive FDA 510(k) clearance?

V.A.C. THERAPY SYSTEM received FDA 510(k) clearance on 2006-10-04, under 510(k) number K062227.

Who is the listed applicant for V.A.C. THERAPY SYSTEM?

The FDA 510(k) record lists Kci USA, Inc. (Kinetic Concepts, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for V.A.C. THERAPY SYSTEM?

The FDA product code for V.A.C. THERAPY SYSTEM is OMP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Kci USA, Inc. (Kinetic Concepts, Inc.) as applicant

K162790V.A.C.ULTA Negative Pressure Wound Therapy System K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings K160451V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...K123878PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING K121883PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT K120499ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM

View all 11 devices →

Related Devices (Code: OMP)

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical K254019Wound Geni NPWT SystemBechtel Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.