510(k) K950300

BARD FLEXIBLE TIP URETERAL CATHETER by C.R. Bard, Inc. — Product Code EYB

K950300 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD FLEXIBLE TIP URETERAL CATHETER". The FDA issued a decision of Substantially Equivalent on April 27, 1995. The device falls under product code EYB (Catheter, Ureteral, Gastro-Urology), a Class II device regulated under 21 CFR 876.5130. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1995
Date Received
January 25, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ureteral, Gastro-Urology
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type