ClearanceBrief
Panels › Cardiovascular › Product code DYE · Class 3

Replacement Heart-Valve

Regulation 870.3925

0510(k)s in 12 months (0 all time)
0recalls in 12 months (8 all time)
0recalls that name a 510(k)
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Top companies in DYE

Company510(k)sRecalls
Medtronic Inc07
Medtronic Cardiovascular Surgery-the Heart Valve Division01
DateFirm and productCodeLinked 510(k)
Jun 26, 2019Medtronic Inc
Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
Terminated
DYENone listed
Jun 26, 2019Medtronic Inc
Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
Terminated
DYENone listed
Jun 26, 2019Medtronic Inc
Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
Terminated
DYENone listed
Jun 26, 2019Medtronic Inc
Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
Terminated
DYENone listed
Jun 26, 2019Medtronic Inc
Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
Terminated
DYENone listed
Sep 11, 2014Medtronic Cardiovascular Surgery-the Heart Valve Division
Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model 105 to provide an alternate method for relief of left ventricul
Terminated
DYENone listed
May 29, 2009Medtronic Inc
Hancock II Bioprostheses with Cinch, Heart Valve, Model # T505 & T510; Catalog #s T505C2501, T505C2101, T505U25ID , T505C2301, T505C2301, T505C2501, T505C2101, T510C29ID, T510C25ID, and T510C27ID; Ste
Terminated
DYENone listed
May 29, 2009Medtronic Inc
Medtronic Mosaic Porcine Bioprostheses with Cinch, Heart Valve; Model 305; Catalog #s 305C21AA, 305C2701, 305C2301, 305C2501, and 305C2901; Sterile LC; Rx only; Medtronic Inc 710 Medtronic Parkway, Mi
Terminated
DYENone listed

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