FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OBSIDIO Conformable Embolic
K Number: K242507
·
Decision Oct 3, 2024
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
128
Applicant Total
58
Review Days
42
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Basic Information
- Device Name
- OBSIDIO Conformable Embolic
- K Number
- K242507
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.3300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific
- Date Received
- August 22, 2024
- Decision Date
- October 3, 2024
- 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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