Accu-Chek FlexLink Plus infusion set
FDA 510(k) K143446 · Roche Diagnostics GmbH
510(k) numberK143446
Submission
- Device name
- Accu-Chek FlexLink Plus infusion set
- Applicant
- Roche Diagnostics GmbH
Mannheim, DE - Received
- December 2, 2014
- Decision date
- August 13, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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Questions and answers
When was Accu-Chek FlexLink Plus infusion set cleared by the FDA?
Accu-Chek FlexLink Plus infusion set (K143446) received a 510(k) decision of Substantially Equivalent on August 13, 2015, 254 days after the submission was received.
What is the product code of K143446?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.