Cathscanner II Intravascular Ultrasonic Imaging Sy
FDA 510(k) K926252 · Endosonics Corp.
510(k) numberK926252
Submission
- Device name
- Cathscanner II Intravascular Ultrasonic Imaging Sy
- Applicant
- Endosonics Corp.
Rancho Cordova, CA, US - Received
- December 14, 1992
- Decision date
- October 25, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Cathscanner II Intravascular Ultrasonic Imaging Sy cleared by the FDA?
Cathscanner II Intravascular Ultrasonic Imaging Sy (K926252) received a 510(k) decision of Substantially Equivalent on October 25, 1993, 315 days after the submission was received.
What is the product code of K926252?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.