FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES
K Number: K133447
·
Decision Feb 24, 2014
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
7
Applicant Total
5
Review Days
104
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Basic Information
- Device Name
- EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES
- K Number
- K133447
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Celonova Biosciences, Inc.
- Date Received
- November 12, 2013
- Decision Date
- February 24, 2014
- Product Code
- NAJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| NAJ | Agents, Embolic, For Treatment Of Uterine Fibroids | FDA class 2 | Cardiovascular |
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Other Clearances by Celonova Biosciences, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K141209 | EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES | Aug 7, 2014 | Substantially Equivalent |
| K132675 | EMBOZENE MICROSPHERES | Oct 3, 2013 | Substantially Equivalent |
| K130307 | ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE | Mar 4, 2013 | Substantially Equivalent |
| K073417 | EMBOZENE MICROSPHERES | Dec 15, 2008 | Substantially Equivalent |