Axela Sheath

Basic Information

• Brand Name: Axela Sheath
• Primary DI: 00690103200782
• Version / Model: 9630ES14A
• Catalog Number: 9630ES14A
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-10
• Public Version: 4
• Public Version Date: 2022-07-04
• Public Version Status: Update
• Public Device Record Key: 2a477475-5e94-4801-b384-72c92520a88f

Device Description

Axela Sheath (US)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NPU	Prosthesis, Mitral Valve, Percutaneously Delivered	Unknown		3
NPT	Aortic Valve, Prosthesis, Percutaneously Delivered	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
58865	Vascular catheter introduction set, nonimplantable	A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	No	Active
60246	Mitral transcatheter heart valve bioprosthesis	An implantable xenograft (e.g., bovine) intended to be used to repair/replace a stenosed or regurgitant mitral heart valve, or previously-implanted mitral heart valve prosthesis, and which is implanted with a catheter via percutaneous access (e.g., transfemoral, transapical) while the heart is beating. It is comprised of the xenograft, processed to render the tissue non-viable, attached to a metal framework (which may be covered with a synthetic polymer material) that is expandable in situ; it may also include a synthetic polymer subannular valve anchoring component. Devices to assist implantation (e.g., catheter, introducer) are typically included.	Yes	Active
60245	Aortic transcatheter heart valve bioprosthesis, stent-like framework	An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral, subclavian, aortic) or transapical access while the heart is beating. It is comprised of the xenograft, processed to render the tissue non-viable, attached to an expandable metal framework, which is implanted with an included catheter, and when in situ, may be expanded with a balloon or self-expand. Typically devices associated with implantation (e.g., catheter, introducer) are included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103200782	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P140031	074

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			14F

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place.