FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARTERIAL BLOOD FILTER, #AF-1025
K Number: K820044
·
Decision Jun 29, 1982
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
94
Applicant Total
55
Review Days
173
Basic Information
- Device Name
- ARTERIAL BLOOD FILTER, #AF-1025
- K Number
- K820044
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4260
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- BENTLEY LABORATORIES, INC.
- Date Received
- January 7, 1982
- Decision Date
- June 29, 1982
- Product Code
- DTM
- 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 |
|---|---|---|---|
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | FDA class 2 | Cardiovascular |
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