FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Aveir Retrieval Catheter
K Number: K213494
·
Decision Apr 1, 2022
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
31
Applicant Total
57
Review Days
151
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Basic Information
- Device Name
- Aveir Retrieval Catheter
- K Number
- K213494
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ABBOTT MEDICAL
- Date Received
- November 1, 2021
- Decision Date
- April 1, 2022
- Product Code
- MMX
- 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 |
|---|---|---|---|
| MMX | Device, Percutaneous Retrieval | FDA class 2 | Cardiovascular |
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