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510(k) K080944

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2008
Date Received
April 3, 2008
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

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  • K183035 — Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Tro (May 17, 2019)
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