MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET— 510(k) K140402

Substantially Equivalent

Medsource International, LLC

FDA 510(k) clearance K140402 for MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET, Substantially Equivalent on 2014-04-03. Applicant: Medsource International, LLC.

Clearance details

Applicant: Medsource International, LLC
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2014-02-18
Decision date: 2014-04-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Mound, MN, US

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Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.