SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60)— 510(k) K955534

Name: FDA 510(k) clearance K955534
Creator: U.S. Food and Drug Administration
Published: 1996-08-01

Substantially Equivalent

International Innovations, Inc.

FDA 510(k) clearance K955534 for SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60), Substantially Equivalent on 1996-08-01. Applicant: International Innovations, Inc.. Device class: 2.

Clearance details

Applicant: International Innovations, Inc.
Product code: Code KRA
Device class: Class 2
Regulation: 21 CFR 870.1210
Advisory panel: Cardiovascular
Date received: 1995-12-04
Decision date: 1996-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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Recent devices under product code KRA

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K254051 — Extroducer Infusion Catheter System2026-09-11
K261610 — Verge Microcatheter2026-06-11
K260771 — TruSelect 2.6 Microcatheter2026-05-15
K250794 — InVera Infusion Device2026-03-12
K243534 — Micro Catheter2025-07-30

Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

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.