C-Thv System
FDA 510(k) K113594 · Paieon, Inc.
510(k) numberK113594
Submission
- Device name
- C-Thv System
- Applicant
- Paieon, Inc.
Rosh Haayin, IL - Received
- December 5, 2011
- Decision date
- March 2, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was C-Thv System cleared by the FDA?
C-Thv System (K113594) received a 510(k) decision of Substantially Equivalent on March 2, 2012, 88 days after the submission was received.
What is the product code of K113594?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.