FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW
K Number: K902404
·
Decision Dec 17, 1990
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
83
Applicant Total
331
Review Days
201
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Basic Information
- Device Name
- SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW
- K Number
- K902404
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- 3M Company
- Date Received
- May 30, 1990
- Decision Date
- December 17, 1990
- Product Code
- KFM
- 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 |
|---|---|---|---|
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | FDA class 2 | Cardiovascular |
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