Trufill DCS Orbit Detachable Coil System
FDA 510(k) K093973 · Codman & Shurtleff, Inc.
510(k) numberK093973
Submission
- Device name
- Trufill DCS Orbit Detachable Coil System
- Applicant
- Codman & Shurtleff, Inc.
Raynham, MA, US - Received
- December 24, 2009
- Decision date
- May 26, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Trufill DCS Orbit Detachable Coil System cleared by the FDA?
Trufill DCS Orbit Detachable Coil System (K093973) received a 510(k) decision of Substantially Equivalent on May 26, 2010, 153 days after the submission was received.
What is the product code of K093973?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.