INTRAVASCULAR CATHETER SECURMENT DEVICE— 510(k) K912211

Name: FDA 510(k) clearance K912211
Creator: U.S. Food and Drug Administration
Published: 1991-08-09

Substantially Equivalent

Inman Liebelt Corp.

FDA 510(k) clearance K912211 for INTRAVASCULAR CATHETER SECURMENT DEVICE, Substantially Equivalent on 1991-08-09. Applicant: Inman Liebelt Corp.. Device class: 1.

Clearance details

Applicant: Inman Liebelt Corp.
Product code: Code KMK
Device class: Class 1
Regulation: 21 CFR 880.5210
Advisory panel: General Hospital
Date received: 1991-05-20
Decision date: 1991-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TX, US

Download summary PDF View on FDA.gov ↗

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K905583 — ILC FORCEPS PADS1991-04-12
K903611 — ILC LEG BAG HOLDER1990-10-26
K903610 — O.R. TIP CLEANER1990-10-19

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.