FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONTRAST INJECTION LINES
K Number: K960674
·
Decision Sep 19, 1996
Classifications
1
FEI Numbers
120
Registration Numbers
120
Same Product Code
204
Applicant Total
110
Review Days
212
Basic Information
- Device Name
- CONTRAST INJECTION LINES
- K Number
- K960674
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- B. BRAUN MEDICAL, INC.
- Date Received
- February 20, 1996
- Decision Date
- September 19, 1996
- 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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