FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
CARDIO-PAK BASIC PUMP PACK
K Number: K923231
·
Decision Jul 9, 1993
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
20
Applicant Total
2
Review Days
373
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Basic Information
- Device Name
- CARDIO-PAK BASIC PUMP PACK
- K Number
- K923231
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4390
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Cardio-Med-Associates, Inc.
- Date Received
- July 1, 1992
- Decision Date
- July 9, 1993
- Product Code
- DWE
- 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 |
|---|---|---|---|
| DWE | Tubing, Pump, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Cardio-Med-Associates, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923233 | CARDIO-PAK LAPAROTOMY PACK | Mar 20, 1993 | Unknown |