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
- PAWNonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement2Product Code
- PZXLeft Atrial Appendage Clip, Implantable2Product Code
- K243860AtriClip PRO-Mini LAA Exclusion System (PROM)2Cleared 510(K)
- K234125AtriClip FLEX-Mini LAA Exclusion System (ACHM)2Cleared 510(K)
- K233407AtriClip 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)2Cleared 510(K)
- K232295LAA Exclusion System2Cleared 510(K)
- K220305Syntheon LAA Exclusion System, Syntheon LAA Selection Guide2Cleared 510(K)
- K210293AtriClip LAA Exclusion System2Cleared 510(K)
- K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip2Cleared 510(K)
- K181474ArtiClip LAA Exclusion System2Cleared 510(K)
- SFQElectrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision2Product Code
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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LAA Exclusion System
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K232295
- 510(k) Type
- Special
- Applicant
- Syntheon, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/30/2023
- Days to Decision
- 29 days
- Submission Type
- Summary