VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM

Device, Neurovascular Embolization

Codman & Shurtleff, Inc.

The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Vascular Occlusion System (trufill Pushable Coils), And Trufill Dcs Orbit Detachable Coil Sysem.

Pre-market Notification Details

• Device ID: K123560
• 510k Number: K123560
• Device Name: VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM
• Classification: Device, Neurovascular Embolization
• Applicant: Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350
• Contact: Richard Kimura
• Correspondent: Richard Kimura; Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350
• Product Code: HCG
• CFR Regulation Number: 882.5950 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-11-19
• Decision Date: 2013-01-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10886704029878	K123560	000
10886704029717	K123560	000
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