# K123733: Cardioblate Cryoflex Surgical Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Apr 1, 2013 after 117 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: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K942299 (1995). 45 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121878: Cardioblate Cryoflex Surgical Ablation Probes, Medtronic, Inc. (2012) Summary page 1.

## Most influential descendants
- K191526: Cardioblate CryoFlex Surgical Ablation System (2019), 0 descendants of its own

## Recalls of this device
- Sep 27, 2021 · Class II · Z-0273-2022: There is potential for intermittent electrical connectivity between the console and probe.
- Oct 12, 2020 · Class II · Z-0494-2021: There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
- Oct 12, 2020 · Class II · Z-0495-2021: There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
- Oct 12, 2020 · Class II · Z-0496-2021: There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
- Oct 12, 2020 · Class II · Z-0493-2021: There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

## Indications for use
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 plus CryoFlex Clamp and 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/K123733
Methodology: https://510kreport.com/methodology