# K191526: Cardioblate CryoFlex Surgical Ablation System

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Oct 1, 2019 after 113 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). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123733: Cardioblate Cryoflex Surgical Ablation System, Medtronic, Inc. (2013) Summary page 4.

## Indications for use
For models 60SF2, 60SF3, and 60SF7: The Cardioblate CryoFlex surgical ablation system is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate CryoFlex 7 cm, 10 cm, and 10-S probes and the Surgical Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis. For model 60CM1: The Cardioblate CryoFlex Surgical Ablation System is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate CryoFlex Clamp and Surgical Ablation Probe and the Surgical Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

Source page: https://510kreport.com/device/K191526
Methodology: https://510kreport.com/methodology