FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301
K Number: K072696
·
Decision May 2, 2008
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
209
Applicant Total
4
Review Days
221
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Basic Information
- Device Name
- ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301
- K Number
- K072696
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Ant Hi-Tech Industrial Co., Ltd.
- Date Received
- September 24, 2007
- Decision Date
- May 2, 2008
- 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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