Stockert S5 System and Gas Blender and Sorin C5 System
FDA 510(k) K101046 · Sorin Group Deutschland GmbH
510(k) numberK101046
Submission
- Device name
- Stockert S5 System and Gas Blender and Sorin C5 System
- Applicant
- Sorin Group Deutschland GmbH
North Attleboro, MA, US - Received
- April 14, 2010
- Decision date
- December 9, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTX – Gas Control Unit, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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Questions and answers
When was Stockert S5 System and Gas Blender and Sorin C5 System cleared by the FDA?
Stockert S5 System and Gas Blender and Sorin C5 System (K101046) received a 510(k) decision of Substantially Equivalent on December 9, 2010, 239 days after the submission was received.
What is the product code of K101046?
The FDA product code is DTX – Gas Control Unit, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4300.