FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC.
K Number: K896964
·
Decision Jun 21, 1990
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
187
Applicant Total
475
Review Days
188
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Basic Information
- Device Name
- PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC.
- K Number
- K896964
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Medtronic Vascular
- Date Received
- December 15, 1989
- Decision Date
- June 21, 1990
- Product Code
- DSY
- 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 |
|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | FDA class 2 | Cardiovascular |
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