RACZ EPIDURAL CATHETER— 510(k) K954584

Name: FDA 510(k) clearance K954584
Creator: U.S. Food and Drug Administration
Published: 1996-10-08

Substantially Equivalent

Medic Evaluation Devices & Instruments Corp.

FDA 510(k) clearance K954584 for RACZ EPIDURAL CATHETER, Substantially Equivalent on 1996-10-08. Applicant: Medic Evaluation Devices & Instruments Corp.. Device class: 2.

Clearance details

Applicant: Medic Evaluation Devices & Instruments Corp.
Product code: Code BSO
Device class: Class 2
Regulation: 21 CFR 868.5120
Advisory panel: Anesthesiology
Date received: 1995-10-02
Decision date: 1996-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gloversville, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BSO

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K241410 — EDEN ControlCath2025-02-13
K231242 — Perifix FX Catheter; Contiplex FX Catheter2023-09-15
K230603 — Arrow Non-Stimulating SnapLock Adapter (K-05520-005C) +4 more2023-08-30
K193664 — SubQKath Catheter and Needle Set2020-09-09
K200624 — Percutaneous Introducer2020-04-27

Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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 →

Recalls naming K954584

K-number listed on FDA's recall record

Z-1276-2021 — Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or lessClass II·Terminated·Epimed International, Inc.·20210201

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K954584.

Data sourced from openFDA. This site is unofficial and independent of the FDA.