510(k) K190587
K190587 is an FDA 510(k) premarket notification submitted by AtriCure, Inc. for the device "Coolrail Linear Pen". The FDA issued a decision of Substantially Equivalent on July 24, 2019. The device falls under product code OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue), a Class II device regulated under 21 CFR 878.4400. AtriCure, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2019
- Date Received
- March 7, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- CV
- Submission Type
Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue