Spur Peripheral Retrievable Stent System

Basic Information

• Brand Name: Spur Peripheral Retrievable Stent System
• Primary DI: 00850025525176
• Version / Model: BSPUR460135US
• Company Name: REFLOW MEDICAL, INC.
• Labeler DUNS: 962545294
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-06
• Public Version: 1
• Public Version Date: 2025-06-16
• Public Version Status: New
• Public Device Record Key: b0f43eaa-cf66-4b5e-9408-0368563a9e5b

Device Description

Peripheral Retrievable Stent System; 4mm x 60mm, catheter shaft length 135cm

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: Labeling does not contain MRI Safety Information
• 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
SEU	Peripheral Temporary And Retrievable Stent System	Cardiovascular	870.5110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47932	Peripheral artery stent, bare-metal	A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation, and not intended for connection with an aortic stent. It is made entirely of metal [e.g., Nitinol alloy mesh structure] and typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850025525176	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN240048	000

Device Sizes

Type	Value	Unit	Text
Stent Length	60	Millimeter
Stent Diameter	4	Millimeter
Catheter Length	135	Centimeter