510(k) K032521

BARD DUAL LUMEN URETERAL CATHETER by C.R. Bard, Inc. — Product Code EYB

K032521 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD DUAL LUMEN URETERAL CATHETER". The FDA issued a decision of Substantially Equivalent on November 14, 2003. 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
November 14, 2003
Date Received
August 15, 2003
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