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FDA 510(k)

ARTIA Reconstructive Tissue Matrix Perforated

K-Number: K162752 · 2017-02-24

ApplicantLifecell Corporation
Decision Date2017-02-24
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARTIA Reconstructive Tissue Matrix Perforated is the device name listed in this FDA 510(k) record. The listed applicant is Lifecell Corporation. It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K162752. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTIA Reconstructive Tissue Matrix Perforated?

ARTIA Reconstructive Tissue Matrix Perforated is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Lifecell Corporation. The 510(k) number is K162752.

When did ARTIA Reconstructive Tissue Matrix Perforated receive FDA 510(k) clearance?

ARTIA Reconstructive Tissue Matrix Perforated received FDA 510(k) clearance on 2017-02-24, under 510(k) number K162752.

Who is the listed applicant for ARTIA Reconstructive Tissue Matrix Perforated?

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

What is the FDA product code for ARTIA Reconstructive Tissue Matrix Perforated?

The FDA product code for ARTIA Reconstructive Tissue Matrix Perforated is FTM.

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.

NCT06575192Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult ParticipantsRECRUITING

Other records listing Lifecell Corporation as applicant

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Related Devices (Code: FTM)

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.

K262406EluPro Antibiotic-Eluting BioEnvelopeBoston ScientificK250598Endoform Reconstructive Template - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc.K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, 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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