DeviceClearance

Product code KRA— Cardiovascular

Bullfrog Micro-Infusion Device

Classification name
Catheter, Continuous Flush
Device class
Class 2
Regulation
21 CFR 870.1210
Advisory panel
Cardiovascular
Total cleared
176
First cleared
Most recent

Market context for product code KRA

FDA has cleared 176 devices under product code KRA between 1977 and 2026, filed by 83 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 KRA

Adverse events under product code KRA

product code KRA
Death
234
Injury
1,029
Malfunction
3,012
Other
2
Total
4,277

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 KRA

1–100 of 176

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