# K052570: Tandemheart Transseptal Cannula Set-EF, Model 5140-6221

- Pathway: 510(k) (Traditional)
- Applicant: Cardiacassist, Inc.
- Decided: Jan 17, 2006 after 120 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K854511 (1986). 3 ancestors in all.
9 later devices descend from it; 2 cite it directly.
2 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030398: Cardiacassist Transseptal Cannula Set, Model 5132-6221, Cardiacassist, Inc. (2003) Summary page 1.
- K924642: Medtronic Bio-Medicus Femoral Cannula/Introducer, Medtronic Bio-Medicus, Inc. (1993) Summary page 1.

## Most influential descendants
- K063723: Impella Recover LP 2.5 Percutaneous Cardiac Support System (2008), 7 descendants of its own
- K083111: Impella 5.0 Catheter Family (2009), 3 descendants of its own
- K102726: Cardiohelp System (2011), 2 descendants of its own
- K093801: Impella Controller (2010), 1 descendant of its own
- K133598: Cardiohelp System (2014), 0 descendants of its own

## Recalls of this device
- Dec 2, 2010 · Not classified · Z-0889-2011: Component (Dilator of TandemHeart Transseptal Cannula Set-EF) does not meet specifications

## Indications for use
The TandemHeart Transseptal Cannula Set - EF is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.

Source page: https://510kreport.com/device/K052570
Methodology: https://510kreport.com/methodology