14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55— 510(k) K030502

Clearance details

Applicant

Medcomp

Product code

Code MSD

Device class

Class 2

Regulation

21 CFR 876.5540

Advisory panel

Gastroenterology, Urology

Date received

2003-02-19

Decision date

2003-05-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Harleysville, PA, US

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• K130889 — SPLIT CATH RG2014-04-28
• K123292 — T32013-06-11
• K102966 — 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC2010-12-21
• K091954 — MICRO-STICK SET2010-01-08
• K091953 — PRO-PICC2009-09-16

Death

67

Injury

545

Malfunction

3,661

Total

4,273

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1351-2015 — Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III; AngioDynamics product- Dura-Flow Catheter, Schon XL Catheter; The affected product are insertion kits used to implant the devices packaged-long and short term hemodialysis catheters and infusion catheters.Class II·Terminated·Medical Components, Inc dba MedComp·20150205

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030502.