510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983511Substantially Equivalent

Soft-Line Ij Double Lumen Catheter 11.5Fr X 12Cm, Soft-Line Ij Double Lumen Catheter 11.5Fr X 15Cm, Soft-Line Lumen Cath

Medical Components, Inc., Harleysville PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983511 is the FDA 510(k) clearance record for SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH, a class II device, cleared for Medical Components, Inc. on under FDA product code MPB (Catheter, Hemodialysis, Non-Implanted). FDA records list 72 510(k) clearances for Medical Components, Inc., from to . As of , FDA records show 11 recalls naming K983511.

Clearance record

Decision date
Received
(244 days to decision)
Product code
MPB Catheter, Hemodialysis, Non-Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Medical Components, Inc. 1499 Delp Dr., Harleysville PA
510(k) summary
Statement
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