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FDA 510(k)

VENTURI NPWT V. II ADVANCED VACUUM SYSTEM

K-Number: K090258 · 2009-08-25

ApplicantTalley Medical
Decision Date2009-08-25
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VENTURI NPWT V. II ADVANCED VACUUM 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 2009-08-25 under 510(k) number K090258. 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 NPWT V. II ADVANCED VACUUM SYSTEM?

VENTURI NPWT V. II ADVANCED VACUUM SYSTEM is a medical device that received FDA 510(k) clearance on 2009-08-25. The listed applicant is Talley Medical. The 510(k) number is K090258.

When did VENTURI NPWT V. II ADVANCED VACUUM SYSTEM receive FDA 510(k) clearance?

VENTURI NPWT V. II ADVANCED VACUUM SYSTEM received FDA 510(k) clearance on 2009-08-25, under 510(k) number K090258.

Who is the listed applicant for VENTURI NPWT V. II ADVANCED VACUUM 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 NPWT V. II ADVANCED VACUUM SYSTEM?

The FDA product code for VENTURI NPWT V. II ADVANCED VACUUM 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.

K080897VENTURI NEGATIVE PRESSURE WOUND THERAPY 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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