Skip to content

Hydrofix Vaso Shield

by Mimedx Group, Inc. 2 variants

510(k) K101805

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 10 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESU Traditional NumberK101805 Date8 Apr 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 10 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  • Withdrawn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
OMR
Device Class
Class II
Regulation
21 CFR Part 870.3470
Advisory Committee
Cardiovascular
FDA Decision
SESU

Other devices from Mimedx Group, Inc.