510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K163004Substantially Equivalent

Radifocus Glidewire Advantage Track

Ashitaka Factory of Terumo Coporation, Fujinomiya Shizuoka, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163004 is the FDA 510(k) clearance record for Radifocus Glidewire Advantage Track, a class II device, cleared for Ashitaka Factory of Terumo Coporation on under FDA product code DQX (Wire, Guide, Catheter). FDA records list one 510(k) clearance for Ashitaka Factory of Terumo Coporation. As of , FDA records show no recalls naming K163004.

Clearance record

Decision date
Received
(94 days to decision)
Product code
DQX Wire, Guide, Catheter
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Ashitaka Factory of Terumo Coporation 150 Maimaigi-Cho, Fujinomiya Shizuoka, JP
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 October 2026, January 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20263
February 20260
March 20263
April 20260
May 20261
June 20260
July 20262
August 20260
September 20262
October 20260