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FDA 510(k)

VT Dressing Kits

K-Number: K172725 · 2018-06-08

ApplicantCarilex Medical, Inc.
Decision Date2018-06-08
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VT Dressing Kits is the device name listed in this FDA 510(k) record. The listed applicant is Carilex Medical, Inc.. It received FDA 510(k) clearance on 2018-06-08 under 510(k) number K172725. 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 VT Dressing Kits?

VT Dressing Kits is a medical device that received FDA 510(k) clearance on 2018-06-08. The listed applicant is Carilex Medical, Inc.. The 510(k) number is K172725.

When did VT Dressing Kits receive FDA 510(k) clearance?

VT Dressing Kits received FDA 510(k) clearance on 2018-06-08, under 510(k) number K172725.

Who is the listed applicant for VT Dressing Kits?

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

What is the FDA product code for VT Dressing Kits?

The FDA product code for VT Dressing Kits is OMP.

Other records listing Carilex Medical, 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.

K231646Carilex VT¿200-i NXK173407VT - 100, VT - 200K161410VT·One, VT·One 60days

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.

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.K253429Genadyne ASTRA NPWTGenadyne Biotechnologies, 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.

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