FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VASCUCARE ANGIOPUMP
K Number: K881780
·
Decision Sep 28, 1988
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
20
Applicant Total
3
Review Days
155
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Basic Information
- Device Name
- VASCUCARE ANGIOPUMP
- K Number
- K881780
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4370
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Vascucare, Inc.
- Date Received
- April 26, 1988
- Decision Date
- September 28, 1988
- Product Code
- DWB
- 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 |
|---|---|---|---|
| DWB | Pump, Blood, Cardiopulmonary Bypass, Roller Type | FDA class 2 | Cardiovascular |
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