510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K080944Substantially Equivalent

X-Force Nephrostomy Balloon Dilation Catheter

C.R. Bard Inc, Covington GA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080944 is the FDA 510(k) clearance record for X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER, cleared for C.R. Bard, Inc. on under FDA product code LJE (Catheter, Nephrostomy). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K080944.

Clearance record

Decision date
Received
(203 days to decision)
Product code
LJE Catheter, Nephrostomy
Device class
Unclassified
Review panel
Unknown
Applicant
C.R. Bard, Inc. 13183 Harland Dr., Covington GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LJE

Trailing 12 months

FDA records hold no clearances under product code LJE in the trailing twelve months.

FDA records show no clearances under product code LJE in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LJE, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260