Microsound 6.6F Diagnostic Imaging Catheter Model 50302, Intravascular Ultrasound Imaging System
FDA 510(k) K950276 · Endosonics Corp.
510(k) numberK950276
Submission
- Device name
- Microsound 6.6F Diagnostic Imaging Catheter Model 50302, Intravascular Ultrasound Imaging System
- Applicant
- Endosonics Corp.
Rancho Cordova, CA, US - Received
- January 23, 1995
- Decision date
- September 22, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Microsound 6.6F Diagnostic Imaging Catheter Model 50302, Intravascular Ultrasound Imaging System cleared by the FDA?
Microsound 6.6F Diagnostic Imaging Catheter Model 50302, Intravascular Ultrasound Imaging System (K950276) received a 510(k) decision of Substantially Equivalent on September 22, 1995, 242 days after the submission was received.
What is the product code of K950276?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.