On-X Mitral Heart Valve with Standard Sewing Ring

GUDID 00851788001280

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.

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• Primary Device ID: 00851788001280
• NIH Device Record Key: 78b53a96-25f1-4860-a183-5c543dddc92e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: On-X Mitral Heart Valve with Standard Sewing Ring
• Version Model Number: ONXM-27/29
• Company DUNS: 844782318
• Company Name: ON-X LIFE TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851788001280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000037

FDA Product Code

• LWQ: Heart-Valve, Mechanical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-12

On-Brand Devices [On-X Mitral Heart Valve with Standard Sewing Ring]

• 00851788001297: The On-X® Prosthetic Heart Valve is a bileaflet mechanical heart valve, which consists of an or
• 00851788001280: The On-X® Prosthetic Heart Valve is a bileaflet mechanical heart valve, which consists of an or
• 00851788001273: The On-X® Prosthetic Heart Valve is a bileaflet mechanical heart valve, which consists of an or