FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORIGEN BLADDER HOLDER
K Number: K003145
·
Decision Apr 20, 2001
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
29
Applicant Total
4
Review Days
192
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Basic Information
- Device Name
- ORIGEN BLADDER HOLDER
- K Number
- K003145
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Origen Biomedical, Inc.
- Date Received
- October 10, 2000
- Decision Date
- April 20, 2001
- Product Code
- DWC
- 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 |
|---|---|---|---|
| DWC | Controller, Temperature, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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