FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C
K Number: K052372
·
Decision Sep 22, 2005
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
400
Applicant Total
29
Review Days
23
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Basic Information
- Device Name
- MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C
- K Number
- K052372
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Perfusion Systems
- Date Received
- August 30, 2005
- Decision Date
- September 22, 2005
- Product Code
- DWF
- 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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| K080824 | BIO-CONSOLE 560 | May 7, 2008 | Substantially Equivalent |
| K061254 | EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 | Jun 23, 2006 | Substantially Equivalent |
| K052524 | BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT | Nov 22, 2005 | Substantially Equivalent |
| K051303 | BIO-CONSOLE, MODEL 560 | Jun 10, 2005 | Substantially Equivalent |
| K051040 | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | May 24, 2005 | Substantially Equivalent |