DeviceClearance

Product code PDU— Cardiovascular

LimFlow ARC

Classification name
Catheter For Crossing Total Occlusions
Device class
Class 2
Regulation
21 CFR 870.1250
Advisory panel
Cardiovascular
Total cleared
58
First cleared
Most recent

FDA classification definition

“To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.”

— U.S. Food and Drug Administration, device classification record for product code PDU under 21 CFR 870.1250, via openFDA

Market context for product code PDU

FDA has cleared 58 devices under product code PDU between 2003 and 2026, filed by 28 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

last 15 years

Top applicants under product code PDU

Adverse events under product code PDU

product code PDU
Malfunction
793
Total
793

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 PDU

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