DeviceClearance

Product code PEH— Gastroenterology, Urology

CLEARGUARD HD END CAP

Classification name
Hemodialysis Catheter Luer End Cap
Device class
Class 2
Regulation
21 CFR 876.5540
Advisory panel
Gastroenterology, Urology
Total cleared
2
First cleared
Most recent

FDA classification definition

“For use in hemodialysis catheters to reduce hub infection.”

— U.S. Food and Drug Administration, device classification record for product code PEH under 21 CFR 876.5540, via openFDA

Market context for product code PEH

FDA has cleared 2 devices under product code PEH between 2013 and 2018, filed by 1 applicant company. 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 PEH

Recent clearances under product code PEH

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