FOLEY CATHETER TUBE HOLDER NO. 101— 510(k) K924567

Name: FDA 510(k) clearance K924567
Creator: U.S. Food and Drug Administration
Published: 1992-11-23

Substantially Equivalent

Ansley Medical Products, Inc.

FDA 510(k) clearance K924567 for FOLEY CATHETER TUBE HOLDER NO. 101, Substantially Equivalent on 1992-11-23. Applicant: Ansley Medical Products, Inc.. Device class: 1.

Clearance details

Applicant: Ansley Medical Products, Inc.
Product code: Code KMK
Device class: Class 1
Regulation: 21 CFR 880.5210
Advisory panel: General Hospital
Date received: 1992-09-09
Decision date: 1992-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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K941098 — SECURE-SITE1995-08-09
K943147 — STATLOCK CV1994-09-29

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K924566 — RESTRAINT, PROTECTIVE N0. 1031992-11-23
K924568 — TUBE, LEAD, AND CORD HOLDER NO. 1021992-11-23

Adverse events under product code KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

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.