# K190623: Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic
- Decided: May 30, 2019 after 80 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: 10 generations back to K942299 (1995). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080509: Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device, Gemini-Ssurgical Ablation Device, Medtronic, Inc. (2008) Summary page 4.

## Indications for use
Cardioblate 49313 Surgical Ablation Pen The Cardioblate surgical ablation pen is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. Cardioblate 49314 XL Surgical Ablation Pen The Cardioblate XL surgical ablation pen is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

Source page: https://510kreport.com/device/K190623
Methodology: https://510kreport.com/methodology