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510(k) K183051

Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set by Cook Incorporated — Product Code LJE

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
July 16, 2019
Date Received
November 2, 2018
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)
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  • K181713 — Ultraxx Nephrostomy Balloon Catheter Set (August 17, 2018)
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