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)

CardioCel 3D

K-Number: K170951 · 2017-04-28

ApplicantAdmedus Regen Pty, Ltd.
Decision Date2017-04-28
Product CodePSQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CardioCel 3D is a medical device manufactured by Admedus Regen Pty, Ltd.. It received FDA 510(k) clearance on 2017-04-28 under approval number K170951. 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 CardioCel 3D?

CardioCel 3D is a medical device that received FDA 510(k) clearance on 2017-04-28. It is manufactured by Admedus Regen Pty, Ltd.. The 510(k) number is K170951.

When was CardioCel 3D approved by the FDA?

CardioCel 3D received FDA 510(k) clearance on 2017-04-28, under approval number K170951.

What company makes CardioCel 3D?

CardioCel 3D is manufactured by Admedus Regen Pty, Ltd..

What is the FDA product code for CardioCel 3D?

The FDA product code for CardioCel 3D is PSQ.

Other Devices by Admedus Regen Pty, Ltd.

K162579VascuCel K200566ADAPT Tissue

Related Devices (Code: PSQ)

K172085PhotoFix Decellularized Bovine PericardiumCryolife, Inc. K172660Duravess bovine pericardial vascular patchEdwards Lifesciences, LLC K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)Cormatrix Cardiovascular, Inc. K191734MatriStem UBM Pericardial PatchAcell, Inc. K183635PhotoFix Decellularized Bovine PericardiumCryolife, Inc. K200566ADAPT TissueAdmedus Regen Pty, Ltd.

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.

↑