Sorin Connect
FDA 510(k) K170460 · Sorin Group Deutschland GmbH
510(k) numberK170460
Submission
- Device name
- Sorin Connect
- Applicant
- Sorin Group Deutschland GmbH
Munich, DE - Received
- February 15, 2017
- Decision date
- June 8, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2450
- Specialty
- Cardiovascular
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Questions and answers
When was Sorin Connect cleared by the FDA?
Sorin Connect (K170460) received a 510(k) decision of Substantially Equivalent on June 8, 2017, 113 days after the submission was received.
What is the product code of K170460?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.