Hydrocoil Embolic System (Hes)
FDA 510(k) K070656 · MicroVention, Inc.
510(k) numberK070656
Submission
- Device name
- Hydrocoil Embolic System (Hes)
- Applicant
- MicroVention, Inc.
Aliso Viejo, CA, US - Received
- March 9, 2007
- Decision date
- June 15, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Hydrocoil Embolic System (Hes) cleared by the FDA?
Hydrocoil Embolic System (Hes) (K070656) received a 510(k) decision of Substantially Equivalent on June 15, 2007, 98 days after the submission was received.
What is the product code of K070656?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.