510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030268Substantially Equivalent

Niagara Temporary Dual Lumen Catheters; Flexxicon II Temporary Dual Lumen Catheters

C.R. Bard Inc, Salt Lake City UT / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030268 is the FDA 510(k) clearance record for NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS, a class II device, cleared for C.R. Bard, Inc. on under FDA product code MPB (Catheter, Hemodialysis, Non-Implanted). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show one recall naming K030268.

Clearance record

Decision date
Received
(184 days to decision)
Product code
MPB Catheter, Hemodialysis, Non-Implanted
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 PDF
Third party review
No

Clearances, product code MPB

Trailing 12 months

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

FDA records show no clearances under product code MPB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MPB, 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