CONCERTO DETACHABLE COIL SYSTEM

Device, Vascular, For Promoting Embolization

MICRO THERAPEUTICS, INC.

The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Concerto Detachable Coil System.

Pre-market Notification Details

• Device ID: K090046
• 510k Number: K090046
• Device Name: CONCERTO DETACHABLE COIL SYSTEM
• Classification: Device, Vascular, For Promoting Embolization
• Applicant: MICRO THERAPEUTICS, INC. 9775 TOLEDO WAY Irvine, CA 92618
• Contact: Neelu Medhekar
• Correspondent: Neelu Medhekar; MICRO THERAPEUTICS, INC. 9775 TOLEDO WAY Irvine, CA 92618
• Product Code: KRD
• CFR Regulation Number: 870.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-01-07
• Decision Date: 2009-02-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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