HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)

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 (hydrosoft) And Microplex Coil System (hypersoft).

Pre-market Notification Details

• Device ID: K091641
• 510k Number: K091641
• Device Name: HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)
• Classification: Device, Neurovascular Embolization
• Applicant: MICROVENTION, INC. 75 COLUMBIA SUITE A Aliso Viejo, CA 92656 -1408
• Contact: Naomi Gong
• Correspondent: Naomi Gong; MICROVENTION, INC. 75 COLUMBIA SUITE A Aliso Viejo, CA 92656 -1408
• Product Code: HCG
• CFR Regulation Number: 882.5950 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-06-04
• Decision Date: 2009-06-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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