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FDA 510(k)

VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM

K-Number: K080897 · 2008-07-15

ApplicantTalley Medical
Decision Date2008-07-15
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Talley Medical. It received FDA 510(k) clearance on 2008-07-15 under 510(k) number K080897. 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 VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM?

VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-15. The listed applicant is Talley Medical. The 510(k) number is K080897.

When did VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM receive FDA 510(k) clearance?

VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM received FDA 510(k) clearance on 2008-07-15, under 510(k) number K080897.

Who is the listed applicant for VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM?

The FDA 510(k) record lists Talley Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM?

The FDA product code for VENTURI NEGATIVE PRESSURE WOUND 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.

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Other records listing Talley Medical 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.

K090258VENTURI NPWT V. II ADVANCED VACUUM SYSTEMK080763TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT

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

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

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