510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011015Substantially Equivalent

Catheter Repair Kit with Replacement Connector, Model 5587000

C.R. Bard Inc, Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011015 is the FDA 510(k) clearance record for CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000, a class II device, cleared for C.R. Bard, Inc. on under FDA product code NFK (Kit, Repair, Catheter, Hemodialysis). FDA's definition for product code NFK reads: "Hemodialysis Tray". FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K011015.

Clearance record

Decision date
Received
(79 days to decision)
Product code
NFK Kit, Repair, Catheter, Hemodialysis
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
C.R. Bard, Inc. 5425 W. Amelia Earhart Dr., Salt Lake City UT
510(k) summary
Summary
Third party review
No

Clearances, product code NFK

Trailing 12 months

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

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