Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS

K-Number: K032310 · 2003-10-10

ApplicantKinetic Concepts, Inc.
Decision Date2003-10-10
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS is the device name listed in this FDA 510(k) record. The listed applicant is Kinetic Concepts, Inc.. It received FDA 510(k) clearance on 2003-10-10 under 510(k) number K032310. 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 MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS?

MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS is a medical device that received FDA 510(k) clearance on 2003-10-10. The listed applicant is Kinetic Concepts, Inc.. The 510(k) number is K032310.

When did MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS receive FDA 510(k) clearance?

MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS received FDA 510(k) clearance on 2003-10-10, under 510(k) number K032310.

Who is the listed applicant for MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS?

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

What is the FDA product code for MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS?

The FDA product code for MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Kinetic Concepts, Inc. as applicant

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.

K050261V.A.C. GRANUFOAM SILVER PROTECTION DRESSINGK041642V.A.C. GRANUFOAM SILVER DRESSINGK022011V.A.C. ABDOMINAL DRESSINGK021500VACUUM ASSISTED CLOSUREK021501V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMATK020781WET CHAMBER

View all 48 devices →

Related Devices (Code: OMP)

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.

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork MedicalK254019Wound 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.

↑