NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER— 510(k) K111900

Clearance details

Applicant

Teleflexmedical, Inc.

Product code

Code MSD

Device class

Class 2

Regulation

21 CFR 876.5540

Advisory panel

Gastroenterology, Urology

Date received

2011-07-05

Decision date

2011-08-17

Decision

Unknown

Clearance type

Traditional

Location

Reading, 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

• K232469 — Rüsch Latex Gold Foley Catheter2024-08-01
• K212077 — Teleflex Rusch SoftSimplastic Foley Catheters2023-07-27
• K192324 — Sheridan Spiral-Flex Endotracheal Tubes2019-12-06
• K182847 — Hudson RCI Voldyne Volumetric Exerciser2019-07-01
• K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter2019-05-24

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-2159-2026 — NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-SFXM, CS-15232-SFXM; NextStep Retrograde Hemodialysis Catheter, REF: AC-15192-X, AC-15232-X, AC-15272-X, CS-15192-X, CS-15232-X, CS-15272-X, CS-15312-X; NextStep Retrograde Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-XM, CS-15232-XM, CS-15272-XM, CS-15312-XMClass I·Ongoing·ARROW INTERNATIONAL, LLC·20260410
• Z-1007-2015 — The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX, AC-15312-SFX, AC-15422-SFX, CS-15192-SFX, CS-15192-SFXM, CS-15232-SFX, CS-15242-I, CS-15272-SFX, CS-15282-I, CS-15312-SFX, CS-15322-I, CS-15362-I, CS-15422-SFX, CS-15502-SFX, CS-15552-I, CSD-15242-I, CSD-15282-I, and CSD-15322-I. The Arrow Edge Hemodialysis Catheterization Set and NextStep Antegrade Hemodialysis Catheterization Set is indicated for use in attaining long- term vascular access for hemodialysis and apheresis.Class II·Terminated·Arrow International Inc·20130204

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111900.