DeviceClearance

Product code MOF— Cardiovascular

0.014 Willow Guidewire

Classification name
Guide, Wire, Catheter, Neurovasculature
Device class
Class 2
Regulation
21 CFR 870.1330
Advisory panel
Cardiovascular
Total cleared
44
First cleared
Most recent

Market context for product code MOF

FDA has cleared 44 devices under product code MOF between 2011 and 2026, filed by 18 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code MOF

Adverse events under product code MOF

product code MOF
Death
6
Injury
137
Total
143

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code MOF

Data sourced from openFDA. This site is unofficial and independent of the FDA.