510(k) K962921

Device
Bard A-trac Urological Balloon Dilation Catheter
Applicant
C.R. BARD, INC.
510(k) number
K962921
Product code
EZN
Decision
Substantially Equivalent (SESE)
Decision date
1996-10-09
Date received
1996-07-26
Regulation
876.5470
Classification name
Dilator, Catheter, Ureteral
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DONNA J WILSON
Address
8195 Industrial Blvd. Covington GA US 30014 30014

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EZN#

510(k), Device, Applicant table
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K050875U-BALLOON DILATION CATHETERC.R. Bard, Inc.2005-05-26
K043254PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATHOnset Medical Corporation2005-02-10
K040127COOK URETERAL BALLOON DILATION CATHETER SETCook Urological, Inc.2004-04-06