FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES
K Number: K042297
·
Decision Jun 1, 2005
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
184
Applicant Total
1
Review Days
281
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Basic Information
- Device Name
- ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES
- K Number
- K042297
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 882.5950
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acta Vascular Systems, Inc.
- Date Received
- August 24, 2004
- Decision Date
- June 1, 2005
- 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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