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Tandemheart Transseptal Cannula Set-Ef, Model 5140-6221

by Cardiacassist, Inc.

510(k) K052570

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052570 Date17 Jan 2006ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0889-2011 FDA Unclassified (pre-2012) initiated 2 Dec 2010

    Component (Dilator of TandemHeart Transseptal Cannula Set-EF) does not meet specifications

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  • Withdrawn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
DWF
Device Class
Class II
Regulation
21 CFR Part 870.4210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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