DeviceClearance

Product code LDF— Cardiovascular

NUMED BALLOON PACING CATHETER

Classification name
Electrode, Pacemaker, Temporary
Device class
Class 2
Regulation
21 CFR 870.3680
Advisory panel
Cardiovascular
Total cleared
129
First cleared
Most recent

Market context for product code LDF

FDA has cleared 129 devices under product code LDF between 1978 and 2026, filed by 60 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 LDF

Adverse events under product code LDF

product code LDF
Death
19
Injury
188
Malfunction
694
Other
1
Total
902

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 LDF

1–100 of 129

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