FDA.reportPublic FDA data

Artivion, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10634813001451326Artivion, Inc.1Y2026-01-011655 Roberts Blvd NW Kennesaw GA US 30144

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00877234001420AMDS Hybrid Prosthesis ("AMDS") - 40mm (Classic) Straight Stent (28mm collar)1(888) 427-9654customerservice.us@artivion.com
00877234001437AMDS Hybrid Prosthesis ("AMDS") - 40mm – 30mm (Classic) Tapered Stent (28mm collar)1(888) 427-9654customerservice.us@artivion.com
00877234001444AMDS Hybrid Prosthesis ("AMDS") - 55mm Straight Stent (32mm collar)1(888) 427-9654customerservice.us@artivion.com
00877234001451AMDS Hybrid Prosthesis ("AMDS") - 55mm – 40mm Tapered Stent (32mm collar)1(888) 427-9654customerservice.us@artivion.com
00877234001635PhotoFix Decellularized Bovine Pericardium - PhotoFix Decellularized Bovine Pericardium 6cmX8cm Artivion800-438-8285xxx@xx.xx
00877234001642PhotoFix Decellularized Bovine Pericardium - PhotoFix Decellularized Bovine Pericardium 0.8cmX8cm Artivion800-438-8285xxx@xx.xx
00877234001659PhotoFix Decellularized Bovine Pericardium - PhotoFix Decellularized Bovine Pericardium 1cmX6cm Artivion800-438-8285xxx@xx.xx
00877234001666PhotoFix Decellularized Bovine Pericardium - PhotoFix Decellularized Bovine Pericardium 4cmX4cm Artivion800-438-8285xxx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
444191133397456P970029TMR HOLMIUM LASER SYSTEMMNO1999-02-11
444191925887350P250055AMDS Hybrid ProsthesisQSK2026-06-26
444191798918159P010003BIOGLUE SURGICAL ADHESIVEMUQ2001-12-03
444191056892890P000037ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXALWQ2001-05-30
444191230489149K993288SULZER CARBOMEDICS CARDIOFIX PERICARDIUMDXZ1999-12-29
444191196766771K252059CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)OHA2025-10-02
444191113010858K183635PhotoFix Decellularized Bovine PericardiumPSQ2019-02-14
444191251862082K172085PhotoFix Decellularized Bovine PericardiumPSQ2017-12-04
444191304604141K162506PhotoFix Decellularized Bovine PericardiumDXZ2017-03-09
444191827255509K141060CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENTPAW2014-06-06
444191385023296K132105PERCLOT TOPICALQSY2014-04-03
444191875300934K121173CHORD-X EPTFE SUTUREPAW2012-08-16
444191859473680K110581PROPATCH SOFT TISSUE REPAIR MATRIXFTM2012-01-10
444191907617876K101866CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCHDXZ2010-07-23
444191177066783K092021CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)OHA2010-05-25
444191451570215H230007
444191225919225
444191286136525
444191534963166
444191737611073
444191880075672
444192014103801

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXZ32017-03-09
OHA22025-10-02
PSQ22019-02-14
PAW22014-06-06
QSY12014-04-03
FTM12012-01-10
MUQ12001-12-03
LWQ12001-05-30
MNO11999-02-11

GUDID#

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