# P020045: 7F Freezor Cardiac Cryoablation Catheter and CCT.2 Cryoconsole System

- Pathway: PMA
- Applicant: Medtronic Cryocath, LP
- Decided: Apr 17, 2003 after 176 days
- Product code: LPB (Cardiac Ablation Percutaneous Catheter)
- Device class: 3
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Sep 1, 2015 · Class II · Z-2777-2015: An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.
- Aug 4, 2006 · Not classified · Z-1452-06: Outer cartons of catheters were mislabeled with two different reference numbers. The front of the package showed the correct reference number; 207F1, however the section on the top of the box incorrec

Source page: https://510kreport.com/device/P020045
Methodology: https://510kreport.com/methodology