510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K110424Substantially Equivalent

Dignity Mini Port- Attachable; Dignity Mini Port- Pre Attached; Dignity Low Profile Port- Attachable; Dignity Low Profil

Medcomp ( Medical Components), Harleysville PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110424 is the FDA 510(k) clearance record for DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL, a class II device, cleared for Medcomp ( Medical Components) on under FDA product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular). FDA records list 13 510(k) clearances for Medcomp ( Medical Components), from to . As of , FDA records show no recalls naming K110424.

Clearance record

Decision date
Received
(289 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
Medcomp ( Medical Components) 1499 Delp Dr., Harleysville PA
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