LOCALMED INFUSION CATHETER— 510(k) K935349

Name: FDA 510(k) clearance K935349
Creator: U.S. Food and Drug Administration
Published: 1994-10-18

Substantially Equivalent

Localmed, Inc.

FDA 510(k) clearance K935349 for LOCALMED INFUSION CATHETER, Substantially Equivalent on 1994-10-18. Applicant: Localmed, Inc.. Device class: 2.

Clearance details

Applicant: Localmed, Inc.
Product code: Code KRA
Device class: Class 2
Regulation: 21 CFR 870.1210
Advisory panel: Cardiovascular
Date received: 1993-11-05
Decision date: 1994-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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K250794 — InVera Infusion Device2026-03-12
K243534 — Micro Catheter2025-07-30

More clearances from Localmed, Inc.

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K980957 — KAPLAN-SIMPSON INFUSASLEEVE II1998-06-10
K972175 — INFUSASLEEVE IIA (IS-2A)1997-08-28
K952317 — Kaplan-Simpson InfusaSleeve II Catheter1995-06-28
K950615 — KAPLAN-SIMPSON INFUSASLEEVE CATHETER1995-04-19

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.