DeviceClearance

Product code LIT— Cardiovascular

PTA BALLOON CATHETER

Classification name
Catheter, Angioplasty, Peripheral, Transluminal
Device class
Class 2
Regulation
21 CFR 870.1250
Advisory panel
Cardiovascular
Total cleared
403
First cleared
Most recent

Market context for product code LIT

FDA has cleared 403 devices under product code LIT between 1981 and 2026, filed by 118 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 LIT

Adverse events under product code LIT

product code LIT
Death
27
Injury
1,256
Malfunction
12,127
Total
13,410

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 LIT

1–100 of 403

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