DeviceClearance

Product code DRF— Cardiovascular

IntellaMap Orion High Resolution Mapping Catheter

Classification name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Device class
Class 2
Regulation
21 CFR 870.1220
Advisory panel
Cardiovascular
Total cleared
185
First cleared
Most recent

Market context for product code DRF

FDA has cleared 185 devices under product code DRF between 1977 and 2026, filed by 62 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 DRF

Adverse events under product code DRF

product code DRF
Death
127
Injury
1,676
Malfunction
2,003
Other
1
Total
3,807

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 DRF

1–100 of 185

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