FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Disposable High Pressure Injector Syringe
K Number: K152906
·
Decision Nov 22, 2016
Classifications
1
FEI Numbers
120
Registration Numbers
120
Same Product Code
204
Applicant Total
4
Review Days
418
Basic Information
- Device Name
- Disposable High Pressure Injector Syringe
- K Number
- K152906
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
- Date Received
- October 1, 2015
- Decision Date
- November 22, 2016
- Product Code
- DXT
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | FDA class 2 | Cardiovascular |
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