# P100010: Arctic Front Cryocatheter System

- Pathway: PMA
- Applicant: Medtronic Cryocath, LP
- Decided: Dec 17, 2010 after 280 days
- Product code: OAE (Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation)
- Device class: 3
- Recalls of this device: 1 (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
- Aug 29, 2011 · Not classified · Z-0149-2012: Medtronic CryoCath has identified specific lots of Arctic Front CryoAblation Catheters that were distributed with incorrect programming that may result in false expired catheter notifications. Impacte

Source page: https://510kreport.com/device/P100010
Methodology: https://510kreport.com/methodology