The following data is part of a premarket notification filed by Atricure Inc. with the FDA for Atricure Isolator Encompass Ablation System, Glidepath Magnetic Guide.
| Device ID | K210477 |
| 510k Number | K210477 |
| Device Name: | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE |
| Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Applicant | AtriCure Inc. 7555 Innovation Way Mason, OH 45040 |
| Contact | Melissa Smallwood |
| Correspondent | Melissa Smallwood AtriCure Inc. 7555 Innovation Way Mason, OH 45040 |
| Product Code | OCL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-19 |
| Decision Date | 2021-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840143904127 | K210477 | 000 |
| 10840143904110 | K210477 | 000 |
| 30840143903377 | K210477 | 000 |
| 10840143905520 | K210477 | 000 |
| 10840143905209 | K210477 | 000 |
| 30840143904114 | K210477 | 000 |
| 30840143904817 | K210477 | 000 |
| 10840143905834 | K210477 | 000 |