FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Single-use Sterile High-pressure Angiographic Syringes and Accessories
K Number: K241109
·
Decision Aug 22, 2024
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
209
Applicant Total
3
Review Days
122
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Basic Information
- Device Name
- Single-use Sterile High-pressure Angiographic Syringes and Accessories
- K Number
- K241109
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Boon Medical Supply Co., Ltd.
- Date Received
- April 22, 2024
- Decision Date
- August 22, 2024
- Product Code
- DXT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | FDA class 2 | Cardiovascular |
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