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510(k) K051316

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2005
Date Received
May 20, 2005
Clearance Type
Traditional
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)
  • K181735 — Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set (March 27, 2019)
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