FDA 510(k) Applications Submitted by Jonathan McElwee
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160454 |
02/18/2016 |
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip |
ATRICURE, INC. |
| K221358 |
05/11/2022 |
Isolator« Linear Pen (MLP1); Isolator« TranspolarÖ Pen (MAX1, MAX5), Coolrail« Linear Pen (MCR1); Isolator« Synergy Surgical Ablation System (EMR2, EML2); Isolator« SynergyÖ EnCompass Clamp (OLH, OSH) and Guide System; Isolator« Synergy Access Clamp (EMT1 |
AtriCure, Inc |
| K181474 |
06/04/2018 |
ArtiClip LAA Exclusion System |
AtriCure, Inc. |
| K142120 |
08/04/2014 |
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP |
ATRICURE, INC. |
| K142203 |
08/11/2014 |
Atricure Cryo Module System; cryoICE cryoablation probe |
ATRICURE, INC. |
| K152337 |
08/19/2015 |
cryoFORM cryoICE cryoablation probe |
ATRICURE, INC |
| K142441 |
09/02/2014 |
cryoICE croablation probe |
ATRICURE, INC. |
| K182565 |
09/18/2018 |
AtriCure cryoICE cryoSPHERE cryoablation probe |
AtriCure, Inc. |
| K163261 |
11/21/2016 |
AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip |
ATRICURE INC. |
| K153500 |
12/07/2015 |
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip |
Atricure, Inc. |
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