EYT — Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile Class I

FDA Device Classification

FDA product code EYT covers "Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile", a Class I medical device regulated under 21 CFR 876.5250. Submissions are reviewed by the Gastroenterology, Urology panel. At least 4 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
EYT
Device Class
Class I
Regulation Number
876.5250
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K934080kit pakURINARY DRAINAGE BAGMay 18, 1994
K935774kendall healthcare products co. div.of tyco healthCURITY FAST-CATH FEMALE CATHETER KITApril 11, 1994
K883057sierra laboratoriesCOMFORT CATH MALE EXTERNAL CATHETERAugust 2, 1988
K883119cook urologicalVPI NON-ADHESIVE CONDOM CATHETERAugust 2, 1988