Skip to content

VitalFlow Set with Balance™ Biosurface

by Medtronic, Inc.

510(k) K261335

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK261335 Date31 Jul 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 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  • Withdrawn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
QJZ
Device Class
Class II
Regulation
21 CFR Part 870.4100
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →