Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Bovine Pericardial Tissue Patch

K-Number: K182493 · 2019-06-18

ApplicantTisgenx
Decision Date2019-06-18
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Bovine Pericardial Tissue Patch is a medical device manufactured by Tisgenx. It received FDA 510(k) clearance on 2019-06-18 under approval number K182493. 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 Bovine Pericardial Tissue Patch?

Bovine Pericardial Tissue Patch is a medical device that received FDA 510(k) clearance on 2019-06-18. It is manufactured by Tisgenx. The 510(k) number is K182493.

When was Bovine Pericardial Tissue Patch approved by the FDA?

Bovine Pericardial Tissue Patch received FDA 510(k) clearance on 2019-06-18, under approval number K182493.

What company makes Bovine Pericardial Tissue Patch?

Bovine Pericardial Tissue Patch is manufactured by Tisgenx.

What is the FDA product code for Bovine Pericardial Tissue Patch?

The FDA product code for Bovine Pericardial Tissue Patch is FTM.

Related Clinical Trials

NCT01757665 ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE) COMPLETED NCT07492576 Evaluation of the Magnesium Shield Compared to Dual Zone Grafting Approach in Immediate Implant Site Management RECRUITING

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.

↑