Cathscanner Intravascular Ultrasonic Imaging Syst.
FDA 510(k) K883888 · Advanced Biosearch Assn.
510(k) numberK883888
Submission
- Device name
- Cathscanner Intravascular Ultrasonic Imaging Syst.
- Applicant
- Advanced Biosearch Assn.
Danville, CA, US - Received
- September 15, 1988
- Decision date
- December 12, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXK – Echocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2330
- Specialty
- Cardiovascular
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Questions and answers
When was Cathscanner Intravascular Ultrasonic Imaging Syst. cleared by the FDA?
Cathscanner Intravascular Ultrasonic Imaging Syst. (K883888) received a 510(k) decision of Substantially Equivalent on December 12, 1988, 88 days after the submission was received.
What is the product code of K883888?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.