SAPPHIRE NXT DETACHABLE COIL SYSTEM

Device, Neurovascular Embolization

MICRO THERAPEUTICS, INC.

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

Pre-market Notification Details

• Device ID: K041649
• 510k Number: K041649
• Device Name: SAPPHIRE NXT DETACHABLE COIL SYSTEM
• Classification: Device, Neurovascular Embolization
• Applicant: MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618
• Contact: Florin Truuvert
• Correspondent: Florin Truuvert; MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618
• Product Code: HCG
• CFR Regulation Number: 882.5950 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-06-17
• Decision Date: 2004-07-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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