# K070288: Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar XL, 60814

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Jun 18, 2007 after 139 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K942299 (1995). 48 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040812: Detect Surgical Pacing and Mapping Tool, Medtronic Vascular (2004) Summary page 2.
- K061593: Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1, AtriCure, Inc. (2006) Summary page 2.
- K013392: Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880, Medtronic Vascular (2002) Summary page 1.
- K031247: Cardioblate Bipolar Radiofrequency Surgical Ablation System, Medtronic Vascular (2003) Summary page 1.

## Most influential descendants
- K090721: Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205 (2009), 1 descendant of its own
- K121451: Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing Device (2012), 0 descendants of its own

## Indications for use
The Cardioblate® Monopolar Pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue using radiofrequency energy when connected to the Cardioblate®generator or for temporary cardiac pacing, sensing, recording and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker.

Source page: https://510kreport.com/device/K070288
Methodology: https://510kreport.com/methodology