SPLIT CATH III— 510(k) K111651

Clearance details

Applicant

Medical Components, Inc.

Product code

Code MSD

Device class

Class 2

Regulation

21 CFR 876.5540

Advisory panel

Gastroenterology, Urology

Date received

2011-06-13

Decision date

2011-12-08

Decision

Unknown

Clearance type

Traditional

Location

Harleysville, PA, US

• K241581 — Hemodialysis Catheter2025-05-16
• K210461 — End Cap2021-09-14
• K203575 — GlidePath Retro Long-Term Hemodialysis Catheter2021-07-01
• K211410 — GlidePath 13F Long-Term Hemodialysis Catheter2021-06-04
• K203767 — Pristine Long-Term Hemodialysis Catheter2021-04-02

• K250836 — 14F Duo-Flow® Side X Side Double Lumen Catheter2025-08-12
• K141633 — PRO-PICC WITH VALVE TECHNOLOGY2014-09-29
• K132880 — MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE2014-01-08
• K131687 — 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET2013-08-16
• K130687 — 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER2013-08-15

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 K111651.