FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT
K Number: K132166
·
Decision Oct 30, 2013
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
167
Applicant Total
44
Review Days
110
Basic Information
- Device Name
- VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT
- K Number
- K132166
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4400
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MAQUET CARDIOPULMONARY AG
- Date Received
- July 12, 2013
- Decision Date
- October 30, 2013
- 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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