# K073605: Atricure Coolrail Linear Pen

- Pathway: 510(k) (Traditional)
- Applicant: AtriCure, Inc.
- Decided: Mar 11, 2008 after 81 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: 7 generations back to K942299 (1995). 40 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050459: Atricure Isolator Transpolar Pen, AtriCure, Inc. (2005) Summary page 1.
- K013392: Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880, Medtronic Vascular (2002) Summary page 1.
- K003978: Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N 102006, P/N 102007, Afx, Inc. (2001) Summary page 1.

## Most influential descendants
- K100501: Multifunctional Linear Pen (2010), 9 descendants of its own
- K113475: Estech Cobra Adhere XL 2 Surgical System (2012), 4 descendants of its own
- K130521: Isolator Linear Pen (2013), 3 descendants of its own
- K122611: Coolrail Linear Pen Model Mcri (2012), 3 descendants of its own
- K183065: Coolrail Linear Pen (2018), 2 descendants of its own

## Indications for use
The CoolrailTM Linear Pen is a sterile, single use electosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

Source page: https://510kreport.com/device/K073605
Methodology: https://510kreport.com/methodology