superDimension Navigation System V7.2
FDA 510(k) K173244 · Covidien, LLC
510(k) numberK173244
Submission
- Device name
- superDimension Navigation System V7.2
- Applicant
- Covidien, LLC
Plymouth, MN, US - Received
- October 6, 2017
- Decision date
- February 8, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was superDimension Navigation System V7.2 cleared by the FDA?
superDimension Navigation System V7.2 (K173244) received a 510(k) decision of Substantially Equivalent on February 8, 2018, 125 days after the submission was received.
What is the product code of K173244?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.