FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER
K Number: K002493
·
Decision Nov 30, 2000
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
94
Applicant Total
43
Review Days
108
Basic Information
- Device Name
- DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER
- K Number
- K002493
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4260
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- COBE CARDIOVASCULAR, INC.
- Date Received
- August 14, 2000
- Decision Date
- November 30, 2000
- Product Code
- DTM
- 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 |
|---|---|---|---|
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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