FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS
K Number: K212057
·
Decision Mar 1, 2022
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
128
Applicant Total
3
Review Days
243
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS
- K Number
- K212057
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Artventive Medical Group, Inc.
- Date Received
- July 1, 2021
- Decision Date
- March 1, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KRD), ordered by most recent decision date.
HARBOR Occlusion Device
FDA 510(k)
FDA Class 2
·Cardiovascular
LOBO Vascular Occlusion System
FDA 510(k)
FDA Class 2
·Cardiovascular
Concerto Versa Detachable Coil
FDA 510(k)
FDA Class 2
·Cardiovascular
Tembo Embolic System
FDA 510(k)
FDA Class 2
·Cardiovascular
OBSIDIO Conformable Embolic (M0013972101010)
FDA 510(k)
FDA Class 2
·Cardiovascular
Polyvinyl Alcohol Embolic Microspheres
FDA 510(k)
FDA Class 2
·Cardiovascular