# K970496: Heartport Maze System: Cryoprobe Set

- Pathway: 510(k) (Traditional)
- Applicant: Heartport, Inc.
- Decided: May 9, 1997 after 88 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
No predicates in its family tree.
393 later devices descend from it; 6 cite it directly.
1 of 394 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Frigitronics® CCS-200 Cardiac Cryosurgical System: named in the summary without a submission number
- (no number) Spembly Medical - Cardiac Cryounit and associated Cardiac Cryoprobes: named in the summary without a submission number

## Most influential descendants
- K974320: Cryogen Cardiac Cryosurgical System (1998), 392 descendants of its own
- 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

## Indications for use
The Heartport™ Maze System: Cryoprobe Set is intended for use in minimally invasive cardiac surgery procedures, including the surgical treatment of cardiac arrhythmias. The cryoprobes are applied to tissue and frozen to cause a block of electrical conduction through tissue by way of an inflammatory response, or cryonecrosis. The Set includes probes of varied tip shapes to optimize access to the treatment site.

Source page: https://510kreport.com/device/K970496
Methodology: https://510kreport.com/methodology