510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K022983Substantially Equivalent

Bardport X-Port Isp Port

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

K022983 is the FDA 510(k) clearance record for BARDPORT X-PORT ISP PORT, a class II device, cleared for C.R. Bard, Inc. on under FDA product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show one recall naming K022983.

Clearance record

Decision date
Received
(16 days to decision)
Product code
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Regulation
21 CFR 880.5965
Device class
Class II
Review panel
General Hospital
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 LJT

Trailing 12 months
1 clearance under product code LJT in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LJT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260