510(k) K913341

BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER by C.R. Bard, Inc. — Product Code EZC

K913341 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER". The FDA issued a decision of Substantially Equivalent on January 27, 1992. 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
SESE (Substantially Equivalent)
Decision Date
January 27, 1992
Date Received
July 26, 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