FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE
K Number: K103762
·
Decision Jan 20, 2011
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
51
Applicant Total
20
Review Days
28
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Basic Information
- Device Name
- SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE
- K Number
- K103762
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4220
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sorin Group Deutschland GmbH
- Date Received
- December 23, 2010
- Decision Date
- January 20, 2011
- 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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Other Clearances by Sorin Group Deutschland GmbH
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|---|---|---|---|
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| K140012 | SORIN FLEXTHERM | Jan 31, 2014 | Substantially Equivalent |
| K131816 | SORIN CONNECT DATA MANAGEMENT SYSTEM | Jul 23, 2013 | Substantially Equivalent |
| K112225 | SORIN CENTRIFUGAL PUMP 5 (CP5) | Sep 20, 2011 | Substantially Equivalent |
| K103468 | STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) | Jan 20, 2011 | Substantially Equivalent |
| K103469 | STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 | Jan 18, 2011 | Substantially Equivalent |
| K103168 | B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) | Jan 6, 2011 | Substantially Equivalent |
| K101046 | STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM | Dec 9, 2010 | Substantially Equivalent |
| K093882 | SORIN C5 SYSTEM MODEL 58-00-00 | Jan 15, 2010 | Substantially Equivalent |