Atlantis PV Imaging Catheter, Model 36456
FDA 510(k) K022860 · Boston Scientific, Target
510(k) numberK022860
Submission
- Device name
- Atlantis PV Imaging Catheter, Model 36456
- Applicant
- Boston Scientific, Target
Fremont, CA, US - Received
- August 28, 2002
- Decision date
- November 21, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Atlantis PV Imaging Catheter, Model 36456 cleared by the FDA?
Atlantis PV Imaging Catheter, Model 36456 (K022860) received a 510(k) decision of Substantially Equivalent on November 21, 2002, 85 days after the submission was received.
What is the product code of K022860?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.