FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PVA FOAM EMBOLIZATION PARTICLES
K Number: K001678
·
Decision Jan 25, 2001
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
184
Applicant Total
3
Review Days
238
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Basic Information
- Device Name
- PVA FOAM EMBOLIZATION PARTICLES
- K Number
- K001678
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5950
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgica Corp.
- Date Received
- June 1, 2000
- Decision Date
- January 25, 2001
- 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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