Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue2Product Code
- K234151Isolator Synergy EnCapture Ablation System (EMH)2Cleared 510(K)
- K221358Isolator® 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)2Cleared 510(K)
- K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device2Cleared 510(K)
- K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE2Cleared 510(K)
- K211311AtriCure Isolator® Synergy™ Surgical Ablation System2Cleared 510(K)
- K200514Cardioblate Gemini-s Surgical Ablation Device2Cleared 510(K)
- K193162EPi-Sense Guided Coagulation System with VisiTrax2Cleared 510(K)
- K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen2Cleared 510(K)
- K191526Cardioblate CryoFlex Surgical Ablation System2Cleared 510(K)
- K190587Coolrail Linear Pen2Cleared 510(K)
Show All 53 Submissions
- PAWNonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement2Product Code
- PZXLeft Atrial Appendage Clip, Implantable2Product Code
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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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)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K221358
- 510(k) Type
- Traditional
- Applicant
- AtriCure, Inc
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/30/2022
- Days to Decision
- 233 days
- Submission Type
- Summary