Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020
FDA 510(k) K060947 · Boston Scientific Corp
510(k) numberK060947
Submission
- Device name
- Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020
- Applicant
- Boston Scientific Corp
Fremont, CA, US - Received
- April 6, 2006
- Decision date
- April 19, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020 cleared by the FDA?
Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020 (K060947) received a 510(k) decision of Substantially Equivalent on April 19, 2006, 13 days after the submission was received.
What is the product code of K060947?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.