FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVTECH LWP*(LOW POROSITY) MWP*(MEDIUM POROSITY)
K Number: K862697
·
Decision Dec 5, 1986
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
187
Applicant Total
1
Review Days
143
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Basic Information
- Device Name
- AVTECH LWP*(LOW POROSITY) MWP*(MEDIUM POROSITY)
- K Number
- K862697
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Advanced Vascular Technologies, Inc.
- Date Received
- July 15, 1986
- Decision Date
- December 5, 1986
- 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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