510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K122468Substantially Equivalent

Asahi Ptca Guide Wire Asahi Sion Blue 180Cm Asahi Ptca Guide Wire Asahi Sion Blue 3300Cm Asahi Ptca Guide Wire Asahi Sio

Asahi Intecc Co., Ltd., Santa Ana CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122468 is the FDA 510(k) clearance record for ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO, a class II device, cleared for Asahi Intecc Co., Ltd. on under FDA product code DQX (Wire, Guide, Catheter). FDA records list 84 510(k) clearances for Asahi Intecc Co., Ltd., from to . As of , FDA records show no recalls naming K122468.

Clearance record

Decision date
Received
(207 days to decision)
Product code
DQX Wire, Guide, Catheter
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Asahi Intecc Co., Ltd. 2500 Red Hill Suite 210, Santa Ana CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQX

Trailing 12 months
12 clearances under product code DQX in the twelve months to November 2026, January 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQX, trailing twelve months
MonthClearances
December 20250
January 20263
February 20260
March 20263
April 20260
May 20261
June 20260
July 20262
August 20260
September 20262
October 20261
November 20260