FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAPIOX SP PUMP HEAD
K Number: K943861
·
Decision Aug 15, 1995
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
82
Applicant Total
21
Review Days
372
Basic Information
- Device Name
- CAPIOX SP PUMP HEAD
- K Number
- K943861
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TERUMO CORP.
- Date Received
- August 8, 1994
- Decision Date
- August 15, 1995
- 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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|---|---|---|---|
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| K040783 | FOUNDATION | Oct 13, 2004 | Substantially Equivalent |
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