ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16

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 Asahi® Peripheral Vascular Guide Wire Asahi Meister®16.

Pre-market Notification Details

• Device ID: K161584
• 510k Number: K161584
• Device Name: ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16
• Classification: Wire, Guide, Catheter
• Applicant: ASAHI INTECC CO.,LTD. 1703 WAKITA-CHO, MORIYAMA-KU Nagoya, JP 463-0024
• Contact: Yoshihiko Fukui
• Correspondent: Candace Cederman; CardioMed Device Consultants, LLC 5523 Research Park Drive Suite 205 Baltimore, MD 21228
• Product Code: DQX
• CFR Regulation Number: 870.1330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-06-08
• Decision Date: 2016-10-06
• Summary: summary