FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
K Number: K163542
·
Decision Jan 31, 2017
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
161
Applicant Total
136
Review Days
46
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Basic Information
- Device Name
- CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
- K Number
- K163542
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.3535
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Datascope Corp.
- Date Received
- December 16, 2016
- Decision Date
- January 31, 2017
- Product Code
- DSP
- 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 |
|---|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | FDA class 2 | Cardiovascular |
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