# K082425: Tandemheart Transseptal Cannula- EF 72

- Pathway: 510(k) (Special)
- Applicant: Cardiacassist, Inc.
- Decided: Sep 18, 2008 after 27 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K854511 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052570: Tandemheart Transseptal Cannula Set-EF, Model 5140-6221, Cardiacassist, Inc. (2006) Summary page 1.
- K030398: Cardiacassist Transseptal Cannula Set, Model 5132-6221, Cardiacassist, Inc. (2003) Summary page 1.
- K872033: Bio-Medicus Cannula-Tubing, Bio Medicus, Inc. (1987) Summary page 1.

## Indications for use
The TandemHeart Transseptal Cannula Set-EF 72 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/K082425
Methodology: https://510kreport.com/methodology