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QuadraSphere Microspheres

by Biosphere Medical, S.A. 3 variants

510(k) K172372

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Overview

The QuadraSphere Microspheres device is a medical device designed to promote embolization, a procedure used to block the flow of blood through a vascular pathway. This device has undergone scrutiny by regulatory authorities and has been found substantially equivalent to an existing medical device.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK172372 Date6 Sep 2017ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KRD
Device Class
Class II
Regulation
21 CFR Part 870.3300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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