510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K120917Substantially Equivalent

Headway Duo Microcatheter

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

K120917 is the FDA 510(k) clearance record for HEADWAY DUO MICROCATHETER, a class II device, cleared for MicroVention, Inc. on under FDA product code DQO (Catheter, Intravascular, Diagnostic). FDA records list 160 510(k) clearances for TERUMO CARDIOVASCULAR SYSTEMS CORPORATION, from to . As of , FDA records show no recalls naming K120917.

Clearance record

Decision date
Received
(128 days to decision)
Product code
DQO Catheter, Intravascular, Diagnostic
Regulation
21 CFR 870.1200
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 DQO

Trailing 12 months
3 clearances under product code DQO in the twelve months to November 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DQO, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260
November 20260