# K060715: Modification to: Cardima Ablation System

- Pathway: 510(k) (Special)
- Applicant: Cardima, Inc.
- Decided: May 15, 2006 after 59 days
- Product code: OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K921884 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022008: Cardima Ablation System, Cardima, Inc. (2003) Summary page 1.

## Recalls of this device
- May 20, 2010 · Not classified · Z-2580-2010: Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could result in patient infection.
- May 20, 2010 · Not classified · Z-2581-2010: Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could result in patient infection.

## Indications for use
The Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

Source page: https://510kreport.com/device/K060715
Methodology: https://510kreport.com/methodology