Search Results
Found 1 results
510(k) Data Aggregation
K Number
K161584Device Name
ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16
Manufacturer
Date Cleared
2016-10-06
(120 days)
Product Code
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
ASAHI INTECC CO.,LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ASAHI Peripheral Vascular Guide Wire is intended for use in the peripheral vasculature, to facilitate the exchange and placement of diagnostic and therapeutic devices such as vascular catheters during peripheral interventional procedures. This guide wire is not intended for use in coronary arteries, lower limb blood vessels, neurovasculature and carotid arteries.
Device Description
The ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 consists of a core wire and a coil assembly. The coil assembly consists of an inner coil and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16. The coil and taper core wire of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 are coated with polyurethane and coated with a hydrophilic polymer upon the polyurethane coat. The distal portion of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 is soft in order to easily bend in accordance with the vessel curve. The ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 is available in various lengths and tip shapes. Accessories such as a Torque device, Shaping device and Inserter are included in the packaging of the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16.
Ask a Question
Ask a specific question about this device
Page 1 of 1