APTUS Heli-FX®

Basic Information

• Brand Name: APTUS Heli-FX®
• Primary DI: 00643169647626
• Version / Model: HG-16-62-28
• 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: 470e8009-1b85-4cdb-805a-0a484d3c9384

Device Description

GUIDE HG-16-62-28 AAA ENDOANCH 62CM 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	00643169647626	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			28 MM Tip Reach Length
Outer Diameter	5.3	Millimeter
Device Size Text, specify			62 CM Sheath Working Length
Device Size Text, specify			.89 MM Maximum Guide Wire Diameter

Storage Conditions

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