Spur Peripheral Retrievable Stent System— 510(k) DEN240048

Unknown

Reflow Medical, Inc.

FDA 510(k) clearance DEN240048 for Spur Peripheral Retrievable Stent System, Unknown on 2025-05-29. Applicant: Reflow Medical, Inc.. Device class: 2.

Clearance details

Applicant: Reflow Medical, Inc.
Product code: Code SEU
Device class: Class 2
Regulation: 21 CFR 870.5110
Advisory panel: Cardiovascular
Date received: 2024-09-20
Decision date: 2025-05-29
Decision: Unknown
Clearance type: Direct
Location: San Clemente, CA, US

View on FDA.gov ↗

More clearances from Reflow Medical, Inc.

K262013 — Kiba CTO Crossing Catheter2026-08-28
K251277 — CoraForce Microcatheter, CoraFlex Microcatheter2025-08-22
K233350 — SINC Support Catheter2024-02-08
K201811 — coraForce and coraFlex Support Catheters2020-10-26
K190393 — Wingman 14C Crossing Catheter2019-05-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.