510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN240048Unknown

Spur Peripheral Retrievable Stent System

ReFlow Medical, Inc, San Clemente CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN240048 is the FDA 510(k) clearance record for Spur Peripheral Retrievable Stent System, a class II device, cleared for Reflow Medical, Inc. on under FDA product code SEU (Peripheral Temporary And Retrievable Stent System). FDA's definition for product code SEU reads: "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...". FDA records list 19 510(k) clearances for Reflow Medical, Inc., from to . As of , FDA records show no recalls naming DEN240048.

Clearance record

Decision date
Received
(251 days to decision)
Product code
SEU Peripheral Temporary And Retrievable Stent System
Regulation
21 CFR 870.5110
Device class
Class II
Review panel
Cardiovascular
Applicant
Reflow Medical, Inc. 208 Avenida Fabricante, Suite 100, San Clemente CA
Third party review
No

Clearances, product code SEU

Trailing 12 months

FDA records hold no clearances under product code SEU in the trailing twelve months.

FDA records show no clearances under product code SEU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SEU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260