The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atricure Coolrail Linear Pen.
Device ID | K073605 |
510k Number | K073605 |
Device Name: | ATRICURE COOLRAIL LINEAR PEN |
Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
Applicant | ATRICURE, INC. 6033 SCHUMACHER PARK DR. West Chester, OH 45069 |
Contact | Alison Grimaldi |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | OCL |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2007-12-21 |
Decision Date | 2008-03-11 |
Summary: | summary |