FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR
K Number: K030449
·
Decision Mar 5, 2003
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
168
Applicant Total
21
Review Days
22
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Basic Information
- Device Name
- MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR
- K Number
- K030449
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4400
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Terumo Corp.
- Date Received
- February 11, 2003
- Decision Date
- March 5, 2003
- 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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