Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V

Q: What is the product code of K100454?

The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.

FDA 510(k) K100454 · MicroVention, Inc.

Substantially Equivalent

510(k) numberK100454

Submission

Device name: Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
Applicant: MicroVention, Inc.
Tistin, CA, US
Received: February 17, 2010
Decision date: April 22, 2010
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HCG – Device, Neurovascular Embolization
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5950
Specialty: Neurology
Implant: Yes

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Questions and answers

When was Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V cleared by the FDA?

Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V (K100454) received a 510(k) decision of Substantially Equivalent on April 22, 2010, 64 days after the submission was received.

What is the product code of K100454?

The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.