DeviceClearance

Product code DXF— Cardiovascular

HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)

Classification name
Catheter, Septostomy
Device class
Class 2
Regulation
21 CFR 870.5175
Advisory panel
Cardiovascular
Total cleared
21
First cleared
Most recent

Market context for product code DXF

FDA has cleared 21 devices under product code DXF between 1980 and 2026, filed by 14 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 DXF

Adverse events under product code DXF

product code DXF
Death
78
Injury
1,126
Malfunction
507
Other
1
Total
1,712

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 DXF

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