FKA — Dilator, Vessel Class II

FDA Device Classification

Classification Details

Product Code
FKA
Device Class
Class II
Regulation Number
876.5540
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K022620spire biomedicalSHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKOctober 11, 2002
K914210vas-cathVAS-CATH DUALATOR(TM) VESSEL DILATORJuly 1, 1993
K910502akcess medical productsVESSEL DILATORSApril 29, 1991