FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CentriMag Acute Circulatory Support System
K Number: K191557
·
Decision Jul 10, 2019
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
36
Applicant Total
1
Review Days
28
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Basic Information
- Device Name
- CentriMag Acute Circulatory Support System
- K Number
- K191557
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4380
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thoratec Corporation (Now Part of Abbott)
- Date Received
- June 12, 2019
- Decision Date
- July 10, 2019
- Product Code
- DWA
- 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 |
|---|---|---|---|
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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