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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 the device name listed in this FDA 510(k) record. The listed applicant is Tisgenx. It received FDA 510(k) clearance on 2019-06-18 under 510(k) 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. The listed applicant is Tisgenx. The 510(k) number is K182493.

When did Bovine Pericardial Tissue Patch receive FDA 510(k) clearance?

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

Who is the listed applicant for Bovine Pericardial Tissue Patch?

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

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

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

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.

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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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