Viewflex Xtra Ice Catheter
FDA 510(k) K121381 · St Jude Medical
510(k) numberK121381
Submission
- Device name
- Viewflex Xtra Ice Catheter
- Applicant
- St Jude Medical
St. Paul, MN, US - Received
- May 8, 2012
- Decision date
- June 7, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Viewflex Xtra Ice Catheter cleared by the FDA?
Viewflex Xtra Ice Catheter (K121381) received a 510(k) decision of Substantially Equivalent on June 7, 2012, 30 days after the submission was received.
What is the product code of K121381?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.