DeviceClearance

Product code KRI— Cardiovascular

3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE

Classification name
Accessory Equipment, Cardiopulmonary Bypass
Device class
Class 1
Regulation
21 CFR 870.4200
Advisory panel
Cardiovascular
Total cleared
42
First cleared
Most recent

Market context for product code KRI

FDA has cleared 42 devices under product code KRI between 1977 and 2002, filed by 28 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code KRI

Recent clearances under product code KRI

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