FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
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)
K Number: K233407
·
Decision Nov 2, 2023
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
8
Applicant Total
59
Review Days
28
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Basic Information
- Device Name
- 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)
- K Number
- K233407
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AtriCure, Inc.
- Date Received
- October 5, 2023
- Decision Date
- November 2, 2023
- Product Code
- PZX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PZX | Left Atrial Appendage Clip, Implantable | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PZX), ordered by most recent decision date.
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Other Clearances by AtriCure, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252056 | Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100) | Jul 24, 2025 | Substantially Equivalent |
| K250371 | cryoICE cryoXT cryoablation probe (cryoXT) | Apr 10, 2025 | Substantially Equivalent |
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM) | Jan 15, 2025 | Substantially Equivalent |
| K243157 | AtriCure cryoICE BOX (ACM) | Oct 29, 2024 | Substantially Equivalent |
| K234151 | Isolator Synergy EnCapture Ablation System (EMH) | Aug 27, 2024 | Substantially Equivalent |
| K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | Jul 29, 2024 | Substantially Equivalent |
| K233959 | EPi-Ease Epicardial Access Device (EAS) | Feb 13, 2024 | Substantially Equivalent |
| K233170 | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) | Oct 26, 2023 | Substantially Equivalent |
| K221358 | 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) | Dec 30, 2022 | Substantially Equivalent |
| K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE | Jul 26, 2021 | Substantially Equivalent |