GUIDE HG
APTUS Heli-FX® - HG-18-90-22
Device Description
A non-bioabsorbable device designed to be implanted into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials/implants (e.g., mesh, sutures); it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is typically a threaded screw-like device, and is made of a material that cannot be chemically degraded or absorbed via natural body processes (e.g., metal, polypropylene); it is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized disposable applicator which may be included.
Environmental Conditions
- Keep Dry
- (10-40° C)(30-75% RH)
Device Sizes
- Outer Diameter: 6.0 Millimeter
- 22 MM Tip Reach Length
- .89 MM Maximum Guide Wire Diameter
- 90 CM Sheath Working Length
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OTD
Device Name: Endovascular Suturing System
Device Class: 2
Physical State: The system is comprised of the implant device and an endovascular delivery device used to implant the endovascular suture.
Definition: Provides fixation and sealing between and endovascular graft and the native artery.
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Uses a metallic implant, delivered through a catheter-based system, to affix the material of an endovascular graft to native vessel
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: The implant is to be placed at the proximal end of an aortic aneurysm.
Regulation Number: 870.3460
Third Party Flag: N
Medical Specialty: CV
Device IdentifiersDevice Id: 00643169647640
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A