FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB
K Number: K052555
·
Decision Mar 15, 2006
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
51
Applicant Total
4
Review Days
180
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Basic Information
- Device Name
- MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB
- K Number
- K052555
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4220
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rand S.R.L.
- Date Received
- September 16, 2005
- Decision Date
- March 15, 2006
- Product Code
- DTQ
- 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 |
|---|---|---|---|
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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