HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V

Device, Neurovascular Embolization

MICROVENTION, INC.

The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Hydrocoil Embolic System-hydroframe Model 100931hfm-v, 101243hfm-v, 180827hfm-v, 181139hfm-v, 181445hfm-v, 181850hfm-v.

Pre-market Notification Details

• Device ID: K100454
• 510k Number: K100454
• Device Name: HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
• Classification: Device, Neurovascular Embolization
• Applicant: MICROVENTION, INC. 1311 VALENCIA AVE Tustin, CA 92780
• Contact: Laraine Pangelina
• Correspondent: Laraine Pangelina; MICROVENTION, INC. 1311 VALENCIA AVE Tustin, CA 92780
• Product Code: HCG
• CFR Regulation Number: 882.5950 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-02-17
• Decision Date: 2010-04-22
• Summary: summary

NIH GUDID Devices

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