Modification to Contour Se Microspheres
FDA 510(k) K032542 · Boston Scientific Corp
510(k) numberK032542
Submission
- Device name
- Modification to Contour Se Microspheres
- Applicant
- Boston Scientific Corp
Glens Falls, NY, US - Received
- August 18, 2003
- Decision date
- September 16, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Modification to Contour Se Microspheres cleared by the FDA?
Modification to Contour Se Microspheres (K032542) received a 510(k) decision of Substantially Equivalent on September 16, 2003, 29 days after the submission was received.
What is the product code of K032542?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.