Product code FHF— Gastroenterology, Urology

CATHETER, MEDIASTINAL&PERICARDIAL

Classification name
System, Evacuator, Fluid
Device class
Class 2
Regulation
21 CFR 876.4370
Advisory panel
Gastroenterology, Urology
Total cleared
3
First cleared
Most recent

Market context for product code FHF

FDA has cleared 3 devices under product code FHF between 1977 and 2010, filed by 3 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

Top applicants under product code FHF

Recent clearances under product code FHF

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