Imager II Urology Torque Catheter
FDA 510(k) K180530 · Boston Scientific Corporation
510(k) numberK180530
Submission
- Device name
- Imager II Urology Torque Catheter
- Applicant
- Boston Scientific Corporation
Marlboro, MA, US - Received
- February 28, 2018
- Decision date
- April 10, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KOD – Catheter, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Imager II Urology Torque Catheter cleared by the FDA?
Imager II Urology Torque Catheter (K180530) received a 510(k) decision of Substantially Equivalent on April 10, 2018, 41 days after the submission was received.
What is the product code of K180530?
The FDA product code is KOD – Catheter, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.