FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS
K Number: K112525
·
Decision Sep 29, 2011
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
95
Applicant Total
1
Review Days
29
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Basic Information
- Device Name
- D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS
- K Number
- K112525
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4260
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Parexel International
- Date Received
- August 31, 2011
- Decision Date
- September 29, 2011
- 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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