FDA 510(k)
FDA class 2
Substantially Equivalent - Market after Inspection
🇺🇸 United States
DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON
K Number: K910997
·
Decision Nov 5, 1991
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
161
Applicant Total
136
Review Days
242
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Basic Information
- Device Name
- DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON
- K Number
- K910997
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3535
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent - Market after Inspection
- Applicant
- Datascope Corp.
- Date Received
- March 8, 1991
- Decision Date
- November 5, 1991
- 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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