FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)
K Number: K223050
·
Decision Dec 21, 2022
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
128
Applicant Total
85
Review Days
83
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Basic Information
- Device Name
- AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)
- K Number
- K223050
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MicroVention, Inc.
- Date Received
- September 29, 2022
- Decision Date
- December 21, 2022
- Product Code
- KRD
- 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 |
|---|---|---|---|
| KRD | Device, Vascular, For Promoting Embolization | FDA class 2 | Cardiovascular |
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