FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIOTOMY RESERVOIR W/FILTER
K Number: K843595
·
Decision Feb 14, 1985
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
168
Applicant Total
4
Review Days
155
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Basic Information
- Device Name
- CARDIOTOMY RESERVOIR W/FILTER
- K Number
- K843595
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4400
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Omnis Surgical, Inc.
- Date Received
- September 12, 1984
- Decision Date
- February 14, 1985
- Product Code
- DTN
- 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 |
|---|---|---|---|
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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