I-ED COIL

Device, Neurovascular Embolization

Kaneka Pharma America LLC

The following data is part of a premarket notification filed by Kaneka Pharma America Llc with the FDA for I-ed Coil.

Pre-market Notification Details

• Device ID: K192068
• 510k Number: K192068
• Device Name: I-ED COIL
• Classification: Device, Neurovascular Embolization
• Applicant: Kaneka Pharma America LLC 546 Fifth Avenue 21st Floor New York, NY 10036
• Contact: Kazuhiko Inoue
• Correspondent: Takeaki Miyata; Kaneka Corporation 1-12-32 Akasaka Minato-ku, JP 107-6028
• Product Code: HCG
• CFR Regulation Number: 882.5950 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-08-01
• Decision Date: 2020-04-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04540778176485	K192068	000
04540778176522	K192068	000
04540778176539	K192068	000
04540778176546	K192068	000
04540778176553	K192068	000
04540778176577	K192068	000
04540778176584	K192068	000
04540778176591	K192068	000
04540778176980	K192068	000
04540778176997	K192068	000
04540778176515	K192068	000
04540778176508	K192068	000
04540778176478	K192068	000
04540778176423	K192068	000
04540778177253	K192068	000
04540778177543	K192068	000
04540778177550	K192068	000
04540778177604	K192068	000
04540778177611	K192068	000
04540778176430	K192068	000
04540778176447	K192068	000
04540778176461	K192068	000
04540778177017	K192068	000
04540778177048	K192068	000
04540778177314	K192068	000
04540778177321	K192068	000
04540778177628	K192068	000
04540778177635	K192068	000
04540778177659	K192068	000
04540778177710	K192068	000
04540778177734	K192068	000
04540778177772	K192068	000
04540778177796	K192068	000
04540778177284	K192068	000
04540778177260	K192068	000
04540778177246	K192068	000
04540778177055	K192068	000
04540778177079	K192068	000
04540778177093	K192068	000
04540778177123	K192068	000
04540778177154	K192068	000
04540778177185	K192068	000
04540778177208	K192068	000
04540778177222	K192068	000
04540778177239	K192068	000
04540778178113	K192068	000