APTUS Heli-FX®

Basic Information

• Brand Name: APTUS Heli-FX®
• Primary DI: 00643169647602
• Version / Model: HA-18-114
• Company Name: MEDTRONIC VASCULAR, INC.
• Labeler DUNS: 080009661
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-21
• Public Version: 6
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: 813ca0f3-c91d-44f7-bdcd-eebfc7359192

Device Description

ACC HA-18-114 TAA APP-CASSETTE 10 MDT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OTD	Endovascular suturing system	Cardiovascular	870.3460	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45612	Soft-tissue/mesh anchor, non-bioabsorbable	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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169647602	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K140036	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			114 CM Sheath Working Length

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: (10-40° C)(30-75% RH)
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry