# K030398: Cardiacassist Transseptal Cannula Set, Model 5132-6221

- Pathway: 510(k) (Traditional)
- Applicant: Cardiacassist, Inc.
- Decided: May 23, 2003 after 106 days
- Product code: DQR (Cannula, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K854511 (1986). 1 ancestor in all.
10 later devices descend from it; 2 cite it directly.
2 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854511: Elecath Percutaneous Left Atrial Cannulation Set, Electro-Catheter Corp. (1986) Summary page 1.

## Most influential descendants
- K052570: Tandemheart Transseptal Cannula Set-EF, Model 5140-6221 (2006), 9 descendants of its own
- 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

## Indications for use
The CardiacAssist Transseptal Cannula Set 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 a suitable extracorporeal blood pump unit which returns blood to the patient via the femoral artery or other appropriate site.

Source page: https://510kreport.com/device/K030398
Methodology: https://510kreport.com/methodology