FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAPIOX BUBBLE TRAP WITH X-COATING
K Number: K090698
·
Decision Jun 8, 2009
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
13
Applicant Total
2
Review Days
83
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Basic Information
- Device Name
- CAPIOX BUBBLE TRAP WITH X-COATING
- K Number
- K090698
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4205
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Terumo Cardiovascular Systems
- Date Received
- March 17, 2009
- Decision Date
- June 8, 2009
- Product Code
- KRL
- 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 |
|---|---|---|---|
| KRL | Detector, Bubble, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Terumo Cardiovascular Systems
| K Number | Device Name | ||
|---|---|---|---|
| K112229 | SARN CENTRIFUGAL PUMP | Dec 9, 2011 | Substantially Equivalent |