Product code SEU

Device name: Peripheral Temporary And Retrievable Stent System
Medical specialty: Cardiovascular
Device class: 2
Regulation number: 870.5110
Review panel: CV
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Definition: A peripheral temporary and retrievable stent system is a temporary scaffold placed into the peripheral vasculature via a delivery catheter system for treating stenotic lesions. The device is designed to be retrieved and removed following successful treatment.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
DEN240048	Spur Peripheral Retrievable Stent System	Reflow Medical, Inc.	2025-05-29

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00850025525169	Spur Peripheral Retrievable Stent System	REFLOW MEDICAL, INC.	2025-06-06
00850025525176	Spur Peripheral Retrievable Stent System	REFLOW MEDICAL, INC.	2025-06-06

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