FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
QuadraSphere Microspheres
K Number: K172372
·
Decision Sep 6, 2017
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
128
Applicant Total
10
Review Days
30
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Basic Information
- Device Name
- QuadraSphere Microspheres
- K Number
- K172372
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.3300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biosphere Medical, S.A.
- Date Received
- August 7, 2017
- Decision Date
- September 6, 2017
- Product Code
- KRD
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| KRD | Device, Vascular, For Promoting Embolization | FDA class 2 | Cardiovascular |
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Other Clearances by Biosphere Medical, S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K250971 | Embosphere Microspheres | May 16, 2025 | Substantially Equivalent |
| K192480 | Torpedo Gelatin Foam | Nov 21, 2019 | Substantially Equivalent |
| K183120 | EmboCube Embolization Gelatin | Aug 6, 2019 | Substantially Equivalent |
| K183578 | Torpedo Gelatin Foam | Jun 18, 2019 | Substantially Equivalent |
| K181021 | EmboCube Embolization Gelatin | Sep 27, 2018 | Substantially Equivalent |
| K181300 | Embosphere Microspheres | Jul 16, 2018 | Substantially Equivalent |
| DEN160040 | Embosphere Microspheres | Jun 21, 2017 | Unknown |
| K153102 | QuadraSphere Microspheres | Nov 23, 2015 | Substantially Equivalent |
| K151187 | QuadraSphere Microspheres | Jul 27, 2015 | Substantially Equivalent |