Syntheon LAA Exclusion System, Syntheon LAA Selection Guide— 510(k) K220305
Substantially EquivalentSyntheon
FDA 510(k) clearance K220305 for Syntheon LAA Exclusion System, Syntheon LAA Selection Guide, Substantially Equivalent on 2022-10-28. Applicant: Syntheon. Device class: 2.
Clearance details
- Applicant
- Syntheon
- Product code
- Code PZX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
Recent devices under product code PZX
view all- K254232 — ECLIPTIS Left Atrial Appendage Exclusion System (4 models)
- K252917 — ATLAAS (Atraumatic Left Atrial Appendage System) (AD)
- K243860 — AtriClip PRO-Mini LAA Exclusion System (PROM)
- K234125 — AtriClip FLEX-Mini LAA Exclusion System (ACHM)
- K233407 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0) +6 more
Adverse events under product code PZX
product code PZX- Death
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.