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FDA 510(k)

ADAPT Tissue

K-Number: K200566 · 2020-04-03

ApplicantAdmedus Regen Pty, Ltd.
Decision Date2020-04-03
Product CodePSQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADAPT Tissue is the device name listed in this FDA 510(k) record. The listed applicant is Admedus Regen Pty, Ltd.. It received FDA 510(k) clearance on 2020-04-03 under 510(k) number K200566. The device is classified under product code PSQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADAPT Tissue?

ADAPT Tissue is a medical device that received FDA 510(k) clearance on 2020-04-03. The listed applicant is Admedus Regen Pty, Ltd.. The 510(k) number is K200566.

When did ADAPT Tissue receive FDA 510(k) clearance?

ADAPT Tissue received FDA 510(k) clearance on 2020-04-03, under 510(k) number K200566.

Who is the listed applicant for ADAPT Tissue?

The FDA 510(k) record lists Admedus Regen Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADAPT Tissue?

The FDA product code for ADAPT Tissue is PSQ.

Other records listing Admedus Regen Pty, Ltd. as applicant

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.

K170951CardioCel 3DK162579VascuCel

Related Devices (Code: PSQ)

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.

K221032Vascu-Guard Vascular Repair PatchSynovis Life Technologies, Inc.K221029PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair PatchSynovis Life Technologies, Inc.K210331CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc.K190882XenoSure Biologic PatchLemaitre VascularK191734MatriStem UBM Pericardial PatchAcell, Inc.K183635PhotoFix Decellularized Bovine PericardiumCryolife, Inc.

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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