510(k) K910846

BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF by C.R. Bard, Inc. — Product Code EZC

K910846 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF". The FDA issued a decision of Substantially Equivalent (kit, denovo) on August 16, 1991. The device falls under product code EZC (Catheter, Coude), 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
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
August 16, 1991
Date Received
February 27, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Coude
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type