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

GUDID 00851788001334

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.

Aortic bi-leaflet mechanical heart valve prosthesis
Primary Device ID00851788001334
NIH Device Record Key1974b550-62c6-40d3-9b42-a7bf49cc179b
Commercial Distribution StatusIn Commercial Distribution
Brand NameOn-X Aortic Heart Valve with Conform-X Sewing Ring
Version Model NumberONXAC-21
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 Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100851788001334 [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

On-Brand Devices [On-X Aortic Heart Valve with Conform-X Sewing Ring]

00851788001488The On-X® Prosthetic Heart Valve is a bileaflet mechanical heart valve, which consists of an or
00851788001365The On-X® Prosthetic Heart Valve is a bileaflet mechanical heart valve, which consists of an or
00851788001358The On-X® Prosthetic Heart Valve is a bileaflet mechanical heart valve, which consists of an or
00851788001341The On-X® Prosthetic Heart Valve is a bileaflet mechanical heart valve, which consists of an or
00851788001334The On-X® Prosthetic Heart Valve is a bileaflet mechanical heart valve, which consists of an or
00851788001327The On-X® Prosthetic Heart Valve is a bileaflet mechanical heart valve, which consists of an or
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