FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6
K Number: K092177
·
Decision Oct 15, 2009
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
35
Applicant Total
4
Review Days
86
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Basic Information
- Device Name
- MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6
- K Number
- K092177
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Invatec S.P.A.
- Date Received
- July 21, 2009
- Decision Date
- October 15, 2009
- Product Code
- NTE
- 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 |
|---|---|---|---|
| NTE | Temporary Carotid Catheter For Embolic Capture | FDA class 2 | Cardiovascular |
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