AneuGuide— 510(k) K213838
Substantially EquivalentArteryFlow Technology Co., Ltd.
FDA 510(k) clearance K213838 for AneuGuide, Substantially Equivalent on 2022-06-01. Applicant: ArteryFlow Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- ArteryFlow Technology Co., Ltd.
- Product code
- Code PZO
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou City, CN
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