FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR
K Number: K954850
·
Decision Oct 30, 1996
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
253
Applicant Total
645
Review Days
373
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Basic Information
- Device Name
- BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR
- K Number
- K954850
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4350
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- C.R. Bard, Inc.
- Date Received
- October 23, 1995
- Decision Date
- October 30, 1996
- Product Code
- DTZ
- 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 |
|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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