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AtriCure, Inc. FDA Approvals
0 new drug approvals and 13 device clearances on file. Matched by name to ATRC.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)510(k)Jul 24, 2025General, Plastic Surgery |
| cryoICE cryoXT cryoablation probe (cryoXT)510(k)Apr 10, 2025Neurology |
| AtriClip PRO-Mini LAA Exclusion System (PROM)510(k)Jan 15, 2025General, Plastic Surgery |
| AtriCure cryoICE BOX (ACM)510(k)Oct 29, 2024Neurology |
| Isolator Synergy EnCapture Ablation System (EMH)510(k)Aug 27, 2024General, Plastic Surgery |
| AtriClip FLEX-Mini LAA Exclusion System (ACHM)510(k)Jul 29, 2024General, Plastic Surgery |
| EPi-Ease Epicardial Access Device (EAS)510(k)Feb 13, 2024Cardiovascular |
| AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV)510(k)Nov 2, 2023General, Plastic Surgery |
| cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)510(k)Oct 26, 2023Neurology |
| Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)510(k)Dec 30, 2022General, Plastic Surgery |
| AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE510(k)Jul 26, 2021General, Plastic Surgery |
| AtriCure Isolator® Synergy Surgical Ablation System510(k)May 28, 2021General, Plastic Surgery |
| AtriClip LAA Exclusion System510(k)Mar 3, 2021General, Plastic Surgery |