ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO— 510(k) K122468

Clearance details

Applicant

Asahi Intecc Co., Ltd.

Product code

Code DQX

Device class

Class 2

Regulation

21 CFR 870.1330

Advisory panel

Cardiovascular

Date received

2012-08-13

Decision date

2013-03-08

Decision

Substantially Equivalent

Clearance type

Special

Location

Santa Ana, CA, US

• K261281 — CROSSLEAD Standard 035 and CROSSLEAD Stiff 0352026-09-03
• K253667 — Accoat Guide Wire2026-07-14
• K261640 — Merit MAK Nitinol/Gold-Tungsten Guide Wire2026-07-13
• K254137 — InQwire Amplatz Guide Wire2026-05-22
• K260544 — FMD Peripheral Guide Wire F-14 Flex 6 +4 more2026-03-20

• K254178 — SAYA 86 Radial Access Guide Catheter2026-05-11
• K252011 — CHIKAI Nexus petit2026-02-02
• K251240 — Branchor X Balloon Guide Catheter2025-06-20
• K251560 — FUBUKI XF-R Neurovascular Long Sheath2025-06-20
• K243383 — CHIKAI Nexus 0142025-04-21

Death

298

Injury

4,385

Malfunction

7,203

Other

5

Total

11,891

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →