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
K141218Substantially Equivalent

Zigiwire Mode2 Guidewire Wire System, Zigiwire Mode3 Guidewire Wire System

Vadiswire Corporation, Kirkland WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141218 is the FDA 510(k) clearance record for ZIGIWIRE MODE2 GUIDEWIRE WIRE SYSTEM, ZIGIWIRE MODE3 GUIDEWIRE WIRE SYSTEM, a class II device, cleared for Vadiswire Corporation on under FDA product code DQX (Wire, Guide, Catheter). FDA records list one 510(k) clearance for Vadiswire Corporation. As of , FDA records show no recalls naming K141218.

Clearance record

Decision date
Received
(220 days to decision)
Product code
DQX Wire, Guide, Catheter
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Vadiswire Corporation 339 Kirkland Way #G, Kirkland WA
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