FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
K Number: K023878
·
Decision Jan 24, 2003
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
21
Applicant Total
468
Review Days
64
Basic Information
- Device Name
- GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
- K Number
- K023878
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDTRONIC VASCULAR
- Date Received
- November 21, 2002
- Decision Date
- January 24, 2003
- Product Code
- NFA
- 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 |
|---|---|---|---|
| NFA | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection | FDA class 2 | Cardiovascular |
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