FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
G.E. STERILE ANGIOGRAPHIC TRAY
K Number: K960139
·
Decision Apr 19, 1996
Classifications
1
FEI Numbers
313
Registration Numbers
313
Same Product Code
70
Applicant Total
169
Review Days
94
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Basic Information
- Device Name
- G.E. STERILE ANGIOGRAPHIC TRAY
- K Number
- K960139
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.4500
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- GE Medical Systems
- Date Received
- January 16, 1996
- Decision Date
- April 19, 1996
- Product Code
- DWS
- 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 |
|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | FDA class 1 | Cardiovascular |
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