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FDA 510(k)

Biodesign Diaphragmatic Hernia Graft

K-Number: K171817 · 2018-03-13

ApplicantCook Biotech Incorporated
Decision Date2018-03-13
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Biodesign Diaphragmatic Hernia Graft is a medical device manufactured by Cook Biotech Incorporated. It received FDA 510(k) clearance on 2018-03-13 under approval number K171817. 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 Biodesign Diaphragmatic Hernia Graft?

Biodesign Diaphragmatic Hernia Graft is a medical device that received FDA 510(k) clearance on 2018-03-13. It is manufactured by Cook Biotech Incorporated. The 510(k) number is K171817.

When was Biodesign Diaphragmatic Hernia Graft approved by the FDA?

Biodesign Diaphragmatic Hernia Graft received FDA 510(k) clearance on 2018-03-13, under approval number K171817.

What company makes Biodesign Diaphragmatic Hernia Graft?

Biodesign Diaphragmatic Hernia Graft is manufactured by Cook Biotech Incorporated.

What is the FDA product code for Biodesign Diaphragmatic Hernia Graft?

The FDA product code for Biodesign Diaphragmatic Hernia Graft is FTM.

Related Clinical Trials

NCT07577414 Safety and Efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Congenital Diaphragmatic Hernia (CDH) NOT_YET_RECRUITING NCT07564297 North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia NOT_YET_RECRUITING NCT06281717 Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia WITHDRAWN

Other Devices by Cook Biotech Incorporated

K162741AxoGuard Nerve Connector K160136Flowable Wound Matrix K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug K161000Biodesign Otologic Repair Graft K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft K162934Biodesign Parastomal Hernia Repair Graft

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Related Devices (Code: FTM)

K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited) K162554Gentrix Surgical MatrixAcell, Inc. K160181COLORADO THERAPEUTICS XENOGRAFT IMPLANTColorado Therapeutics, LLC K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)

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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