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ReShape™ Valve Sealant - component for use with the ReShape™ Integrated Dual Balloon
RESHAPE MEDICAL, INC.
RSM900
Not in Commercial Distribution
- B001RSM9001 ()
RSM900
- Appetite-suppression gastric balloon
OBALON® Reference Sensor Cable - component for use with the OBALON® Navigation Console
ReShape Lifesciences Inc.
7404-0001
Not in Commercial Distribution
- 00859810006197 ()
- Gastrointestinal catheter/endoscope tracking system sensor, body-surface
OBALON® Placebo Capsule HPMC - component for use with the OBALON® Balloon System
ReShape Lifesciences Inc.
7650-0002
Not in Commercial Distribution
- 20859810006085 ()
- 00859810006081 ()
- 10859810006088 ()
- Appetite-suppression gastric balloon
LAP-BAND 10.0, ACCESS PORT II, US
Apollo Endosurgery, Inc.
B-2225
Not in Commercial Distribution
- 10811955020176 ()
- 10 cm
B-2225
- Gastric band
N/A
COCHLEAR LIMITED
P1431676
In Commercial Distribution
- 09321502046329 ()
P1431676
- Cochlear implant system electrode array assembly
N/A
COCHLEAR LIMITED
P783831
In Commercial Distribution
- 09321502036580 ()
P783831
- Cochlear implant system electrode array assembly
N/A
COCHLEAR LIMITED
P783829
In Commercial Distribution
- 09321502036573 ()
P783829
- Cochlear implant system electrode array assembly
N/A
COCHLEAR LIMITED
Z285654
In Commercial Distribution
- 09321502032612 ()
Z285654
- Cochlear implant system electrode array assembly
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.
ONXACE-25
In Commercial Distribution
- 00851788001471 ()
- Outer Diameter: 25 Millimeter
- Aortic bi-leaflet mechanical heart valve prosthesis
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.
ONXACE-23
In Commercial Distribution
- 00851788001464 ()
- Outer Diameter: 23 Millimeter
- Aortic bi-leaflet mechanical heart valve prosthesis