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FDA 510(k), K220305, Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
FDA 510(k), K220305, Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
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$945.81 USD
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510(K) Number: K220305
Device Name: Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
Manufacturer: Syntheon
Device Classification Name: Left Atrial Appendage Clip, Implantable
Regulation Number: 878.4300
Classification Product Code: PZX
Date Received: 02/02/2022
Decision Date: 10/28/2022
Regulation Medical Specialty: General & Plastic Surgery
Total Pages: 7,030
Fully Redacted Pages: 6,561
Content Pages: 469
Device Name: Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
Manufacturer: Syntheon
Device Classification Name: Left Atrial Appendage Clip, Implantable
Regulation Number: 878.4300
Classification Product Code: PZX
Date Received: 02/02/2022
Decision Date: 10/28/2022
Regulation Medical Specialty: General & Plastic Surgery
Total Pages: 7,030
Fully Redacted Pages: 6,561
Content Pages: 469
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