FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 1861 BLOOD PUMP
K Number: K780953
·
Decision Aug 31, 1978
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
83
Applicant Total
475
Review Days
83
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Basic Information
- Device Name
- MODEL 1861 BLOOD PUMP
- K Number
- K780953
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Medtronic Vascular
- Date Received
- June 9, 1978
- Decision Date
- August 31, 1978
- 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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