Spur Peripheral Retrievable Stent System

FDA UDI

Class II (US FDA UDI)

by Reflow Medical, Inc.

Identity

Trade Name: Spur Peripheral Retrievable Stent System FDA UDI
Generic Name: Peripheral artery stent, bare-metal FDA UDI
Device Name: Peripheral Retrievable Stent System; 3mm x 65mm, catheter shaft length 135cm FDA UDI
Model / Reference: BSPUR365135US FDA UDI
Description: Peripheral Retrievable Stent System; 3mm x 65mm, catheter shaft length 135cm FDA UDI

Identifiers

Primary DI / UDI-DI: 00850025525169 FDA UDI
510(k) Number: DEN240048 FDA UDI
FDA Product Code: SEU FDA UDI
GMDN Term: Peripheral artery stent, bare-metal FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5110 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Stent Diameter — 3 Millimeter FDA UDI
Stent Length — 65 Millimeter FDA UDI
Shaft Length — 135 Centimeter FDA UDI

Category: Peripheral artery stent, bare-metal

Spur Peripheral Retrievable Stent System by Reflow Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral artery stent, bare-metal.

Innova™ Vascular — Boston Scientific · Class III
Pulsar-18 — Biotronik, Inc. · Class III
LifeStent® Solo Vascular Stent — Bard Peripheral Vascular · Class III
Astron — Biotronik, Inc. · Class III
Absolute Pro — Abbott Vascular · Class III
Protégé™ GPS™ — EV3, INC · Class II
COMPLETE® SE VASCULAR — MEDTRONIC, INC. · Class III
Zilver 518 — Cook Ireland, Ltd. · Class III

Cleared under the same submission

DEN240048 also covers:

Spur Peripheral Retrievable Stent System — REFLOW MEDICAL, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Reflow Medical, Inc.

Sources (1)

FDA UDI 5b10b590-24e5-4657-bab3-683ebf4dec80 36 fields · synced May 30, 2026