FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BARD ISOFLOW BLOOD PUMP
K Number: K971421
·
Decision May 14, 1998
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
36
Applicant Total
645
Review Days
393
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Basic Information
- Device Name
- BARD ISOFLOW BLOOD PUMP
- K Number
- K971421
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4380
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- C.R. Bard, Inc.
- Date Received
- April 16, 1997
- Decision Date
- May 14, 1998
- Product Code
- DWA
- 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 |
|---|---|---|---|
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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