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510(k) K200566

Device
ADAPT Tissue
Applicant
Admedus Regen Pty Ltd
510(k) number
K200566
Product code
DXZ  
Decision
Substantially Equivalent (SESE)
Decision date
2020-04-03
Date received
2020-03-04
Regulation
870.3470
Classification name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kiran Bhirangi
Address
26 Harris Rd. Malaga AU 6080 6080

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DXZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240775PeriBeam® Pericardial MembraneTamabio2025-04-18
K200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchVascutek, Ltd.2020-07-08
K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc.2017-03-09
K162579VascuCelAdmedus Regen Pty, Ltd.2016-10-14
K152127CorMatrix TykeCormatrix Cardiovascular, Inc.2016-02-04
K151865PremiPatch PTFE PledgetAesculap, Inc.2015-10-27
K142447PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair PatchSynovis Life Technologies, Inc.2015-01-07
K142461VASCU-GUARD Peripheral Vascular PatchSynovis Life Technologies, Inc.2014-11-25
K140789CORMATRIX ECM FOR VASCULAR REPAIRCormatrix Cardiovascular, Inc.2014-07-15
K130872CARDIOCELCelxcel Pty, Ltd.2014-01-30
K122306SYNOVIS COLLAGEN MATRIX (TBD)Synovis Surgical Innovations2013-03-08
K122105SMI CARDIOVASCULAR PATCHSolinas Medical, Inc.2012-12-07
K112683SMI CARDIOVASCULAR PACHSolimas Medical, Inc.2011-12-14
K111187PATCH, PLEDGET AND INTRACARDIACCormatrix Cardiovascular, Inc.2011-07-26
K101740ALBOSURE POLYESTER VASCULAR PATCHLeMaitre Vascular, Inc.2010-09-20

Legacy Summary#

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FDA Review#

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