FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
M-BOLUS EMBOLIC MICROSPHERES
K Number: K052509
·
Decision Dec 11, 2006
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
184
Applicant Total
4
Review Days
454
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Basic Information
- Device Name
- M-BOLUS EMBOLIC MICROSPHERES
- K Number
- K052509
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 882.5950
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Scion Cardio-Vascular, Inc.
- Date Received
- September 13, 2005
- Decision Date
- December 11, 2006
- Product Code
- HCG
- 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 |
|---|---|---|---|
| HCG | Device, Neurovascular Embolization | FDA class 2 | Neurology |
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