TREASURE

Wire, Guide, Catheter

ASAHI INTECC CO., LTD.

The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Treasure.

Pre-market Notification Details

• Device ID: K061984
• 510k Number: K061984
• Device Name: TREASURE
• Classification: Wire, Guide, Catheter
• Applicant: ASAHI INTECC CO., LTD. 1301 DOVE STREET, SUITE #350 Newport Beach, CA 92660
• Contact: Yoshi Terai
• Correspondent: Yoshi Terai; ASAHI INTECC CO., LTD. 1301 DOVE STREET, SUITE #350 Newport Beach, CA 92660
• Product Code: DQX
• CFR Regulation Number: 870.1330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-07-13
• Decision Date: 2006-10-05
• Summary: summary