SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F— 510(k) K180994

Name: FDA 510(k) clearance K180994
Creator: U.S. Food and Drug Administration
Published: 2019-07-09

Substantially Equivalent

Interrad Medical, Inc.

FDA 510(k) clearance K180994 for SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F, Substantially Equivalent on 2019-07-09. Applicant: Interrad Medical, Inc.. Device class: 1.

Clearance details

Applicant: Interrad Medical, Inc.
Product code: Code KMK
Device class: Class 1
Regulation: 21 CFR 880.5210
Advisory panel: General Hospital
Date received: 2018-04-16
Decision date: 2019-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KMK

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K981860 — A P HARNESS1999-06-03
K963365 — MULTI-PURPOSE MEDICAL TUBE HOLDER1996-10-11
K941098 — SECURE-SITE1995-08-09
K943147 — STATLOCK CV1994-09-29
K943047 — IV START KITS1994-09-14

More clearances from Interrad Medical, Inc.

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K210629 — SecurAcath2021-04-12
K180769 — SecurAcath2018-06-26
K120935 — SECURACATH2012-04-27
K092306 — SECURACATH UNIVERSAL2010-07-09
K083081 — MODIFICATION TO SECURACATH, MODEL: SPK012009-03-04

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.