On-X Mitral Heart Valve with Conform-X Sewing Ring

GUDID 00851788001303

The On-X® Prosthetic Heart Valve is a bileaflet mechanical heart valve, which consists of an orifice housing and two leaflets. The orifice inflow area has a flared inlet designed to reduce flow turbulence, and the outflow rim consists of leaflet guards designed to protect the leaflets while in the closed position. The leaflets rotate around tabs located within the inner circumference of the orifice ring. In the closed position, each leaflet forms a nominal angle of 40º relative to the plane of the orifice. In the open position, the plane of each leaflet forms a nominal angle of 90deg relative to the plane of the orifice. The leaflets have a travel arc of 50deg to the closed position. The orifice, or housing, is composed of a graphite substrate coated with On-X® Carbon, a pure unalloyed form of pyrolytic carbon. The leaflets consist of On-X® Carbon deposited on a graphite substrate, which is impregnated with 10 weight% tungsten to provide radiopacity. The sewing cuff is constructed of polytetrafluoroethylene (PTFE) fabric mounted on the orifice using titanium retaining rings and 5-0 suture material. This form of sewing cuff attachment to the orifice allows for rotation of the sewing cuff in situ during implantation. Orientation reference marks are provided on the sewing cuff for valve orientation. The On-X® Prosthetic Heart Valve is available in 3 aortic and 2 mitral sewing cuff configurations. Aortic configurations are available in sizes 19, 21, 23, 25, and 27/29 mm. The standard mitral cuff is available in sizes 23, 25, 27/29 and 31/33, while the Conform-X® mitral cuff is available in size 25/33 only. Further detail for the On-X prosthetic heart valve is described in the Summary of Safety and Effectiveness documents for the On-X heart valves: http://www.accessdata.fda.gov/cdrh_docs/pdf/P000037b.pdf (aortic), and http://www.accessdata.fda.gov/cdrh_docs/pdf/P000037S001b.pdf (mitral).

ON-X LIFE TECHNOLOGIES, INC.

Mitral bi-leaflet mechanical heart valve prosthesis
Primary Device ID00851788001303
NIH Device Record Keyf1ad9e75-0238-4ea1-9922-04beed7f95b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameOn-X Mitral Heart Valve with Conform-X Sewing Ring
Version Model NumberONXMC-25/33
Company DUNS844782318
Company NameON-X LIFE TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter33 Millimeter
Outer Diameter33 Millimeter
Outer Diameter33 Millimeter
Outer Diameter33 Millimeter
Outer Diameter33 Millimeter
Outer Diameter33 Millimeter
Outer Diameter33 Millimeter
Outer Diameter33 Millimeter
Outer Diameter33 Millimeter
Outer Diameter33 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100851788001303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWQHeart-Valve, Mechanical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-12

Devices Manufactured by ON-X LIFE TECHNOLOGIES, INC.

00851788001495 - Chord-X Chordal Sizer2023-10-20 for sizing or configuring chordal replacement prostheses during mitral valve repair
00851788001020 - On-X Heart Valve Instruments2023-08-17 Rotator for heart valve size 19. The valve rotator is used for reorienting an in-situ valve and may be used to verify leaflet mo
00851788001037 - On-X Heart Valve Instruments2023-08-17 Rotator For valve size 21. The valve rotator is used for reorienting an in-situ valve and may be used to verify leaflet mobility
00851788001044 - On-X Heart Valve Instruments2023-08-17 Rotator For valve size 23. The valve rotator is used for reorienting an in-situ valve and may be used to verify leaflet mobility
00851788001051 - On-X Heart Valve Instruments2023-08-17 Rotator For valve sizes 25. The valve rotator is used for reorienting an in-situ valve and may be used to verify leaflet mobilit
00851788001068 - On-X Heart Valve Instruments2023-08-17 Aortic Sizers for valve size 19 (Gold).The sizers are used to gauge the resulting tissue annulus diameter after the annulus is p
00851788001082 - On-X Heart Valve Instruments2023-08-17 Aortic SIzers for valve size 19 (grey). The sizers are used to gauge the resulting tissue annulus diameter after the annulus is
00851788001099 - On-X Heart Valve Instruments2023-08-17 Aortic Sizers for valve size 21(grey).The sizers are used to gauge the resulting tissue annulus diameter after the annulus is pr
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