FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT
K Number: K974155
·
Decision Jan 22, 1998
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
167
Applicant Total
503
Review Days
79
Basic Information
- Device Name
- BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT
- K Number
- K974155
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4400
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BAXTER HEALTHCARE CORP.
- Date Received
- November 4, 1997
- Decision Date
- January 22, 1998
- Product Code
- DTN
- 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 |
|---|---|---|---|
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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