FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CENTRI-SAFE(TM) VALVE
K Number: K921500
·
Decision Sep 15, 1992
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
8
Applicant Total
9
Review Days
168
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Basic Information
- Device Name
- CENTRI-SAFE(TM) VALVE
- K Number
- K921500
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4400
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardio Systems, Inc.
- Date Received
- March 31, 1992
- Decision Date
- September 15, 1992
- Product Code
- MJJ
- 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 |
|---|---|---|---|
| MJJ | Cpb Check Valve, Retrograde Flow, In-Line | FDA class 2 | Cardiovascular |
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