Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with the Hydrolink Syringe Kit
FDA 510(k) K022735 · MicroVention, Inc.
510(k) numberK022735
Submission
- Device name
- Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with the Hydrolink Syringe Kit
- Applicant
- MicroVention, Inc.
Aliso Viejo, CA, US - Received
- August 19, 2002
- Decision date
- September 6, 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 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with the Hydrolink Syringe Kit cleared by the FDA?
Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with the Hydrolink Syringe Kit (K022735) received a 510(k) decision of Substantially Equivalent on September 6, 2002, 18 days after the submission was received.
What is the product code of K022735?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.