# K974320: Cryogen Cardiac Cryosurgical System

- Pathway: 510(k) (Traditional)
- Applicant: Cryogen, Inc.
- Decided: Feb 3, 1998 after 78 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: 2 generations back to K811390 (1981). 7 ancestors in all.
392 later devices descend from it; 3 cite it directly.
1 of 400 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811390: CCS100 Cryosurgical System, Frigitronics of Connecticut, Inc. (1981) Summary page 1.
- K874367: Various Cardiac Cryoprobes Having Dia. & Cos. Diff, Spembly Medical, Ltd. (1988) Summary page 1.
- K970496: Heartport Maze System: Cryoprobe Set, Heartport, Inc. (1997) Summary page 1.
- K972662: Cryogen Cryosurgical System, Cryogen, Inc. (1997) Summary page 1.

## Most influential descendants
- K013946: Flex 10 Accessory for the Afx Microwave Ablation System (2002), 340 descendants of its own
- K041340: Guidant Microwave Ablation System (2004), 268 descendants of its own
- K043153: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 & IS1000 (2004), 251 descendants of its own
- K050005: Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model 400180 (2005), 231 descendants of its own
- K050369: Intuitive Surgical DA Vinci Surgical System, Model IS2000 (2005), 230 descendants of its own

## Indications for use
The CryoGen Cardiac Cryosurgical System is indicated for use in minimaily invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. The cardiac cryoprobes freeze the target tissue and block the electrical conduction pathway by creating an inflammatory response, or cryonecrosis.

Source page: https://510kreport.com/device/K974320
Methodology: https://510kreport.com/methodology