CONCORD/PORTEX EPIDURAL CATHETERS— 510(k) K935927

Name: FDA 510(k) clearance K935927
Creator: U.S. Food and Drug Administration
Published: 1994-09-09

Substantially Equivalent

Smiths Industries Medical Systems, Inc.

FDA 510(k) clearance K935927 for CONCORD/PORTEX EPIDURAL CATHETERS, Substantially Equivalent on 1994-09-09. Applicant: Smiths Industries Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Smiths Industries Medical Systems, Inc.
Product code: Code BSO
Device class: Class 2
Regulation: 21 CFR 868.5120
Advisory panel: Anesthesiology
Date received: 1993-12-13
Decision date: 1994-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keene, NH, US

Download summary PDF View on FDA.gov ↗

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K962931 — SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT1996-10-21
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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 →

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