FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TEMPORARY TITANIUM ANEURYSM CLIP
K Number: K031468
·
Decision Jun 20, 2003
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
35
Applicant Total
32
Review Days
42
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Basic Information
- Device Name
- TEMPORARY TITANIUM ANEURYSM CLIP
- K Number
- K031468
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5200
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardinalhealth
- Date Received
- May 9, 2003
- Decision Date
- June 20, 2003
- Product Code
- HCH
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HCH | Clip, Aneurysm | FDA class 2 | Neurology |
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