FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHEAR FORCE GAUGE
K Number: K864330
·
Decision Jan 6, 1987
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
73
Applicant Total
89
Review Days
63
Basic Information
- Device Name
- SHEAR FORCE GAUGE
- K Number
- K864330
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- AMERICAN EDWARDS LABORATORIES
- Date Received
- November 4, 1986
- Decision Date
- January 6, 1987
- Product Code
- DXE
- 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 |
|---|---|---|---|
| DXE | Catheter, Embolectomy | FDA class 2 | Cardiovascular |
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