510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K161803Substantially Equivalent

Traxcess .007 Mini Guidewire

Terumo Cardiovascular Systems Corporation, Tistin CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161803 is the FDA 510(k) clearance record for Traxcess .007 Mini Guidewire, a class II device, cleared for MicroVention, Inc. on under FDA product code MOF (Guide, Wire, Catheter, Neurovasculature). FDA records list 160 510(k) clearances for TERUMO CARDIOVASCULAR SYSTEMS CORPORATION, from to . As of , FDA records show one recall naming K161803.

Clearance record

Decision date
Received
(92 days to decision)
Product code
MOF Guide, Wire, Catheter, Neurovasculature
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
MicroVention, Inc. 1311 Valencia Ave., Tistin CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MOF

Trailing 12 months
12 clearances under product code MOF in the twelve months to October 2026, August 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MOF, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20262
March 20262
April 20262
May 20260
June 20260
July 20261
August 20263
September 20261
October 20260