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510(k) Data Aggregation
K Number
K182493Device Name
Bovine Pericardial Tissue Patch
Manufacturer
Date Cleared
2019-06-18
(280 days)
Product Code
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Tisgenx
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Tisgenx's Bovine Pericardial Tissue Patch is intended for use as a surgical patch for cardiac and vascular reconstruction and repair, soft tissue deficiency repair, and reinforcing the suture line during general surgical procedures.
Device Description
The Tisqenx Bovine Pericardial Tissue Patch is a bovine pericardium that is chemically crosslinked using a glutaraldehyde solution to impart stability. The device is provided terminally sterile, packaged in a sterile barrier jar filed with a liquid chemical sterilant. The device is intended for single patient use as a surgical patch for cardiac and vascular reconstruction and repair, soft tissue deficiency reconstruction and repair, and reinforcing the suture line during general surgical procedures.
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