510(k) K063632

X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER by C.R. Bard, Inc. — Product Code LJE

K063632 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER". The FDA issued a decision of Substantially Equivalent on January 5, 2007. The device falls under product code LJE (Catheter, Nephrostomy), a Class U device. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2007
Date Received
December 6, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Nephrostomy
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type