BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE— 510(k) K092318

Substantially Equivalent

Baxter Healthcare Corporation

FDA 510(k) clearance K092318 for BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE, Substantially Equivalent on 2009-10-30. Applicant: Baxter Healthcare Corporation.

Clearance details

Applicant: Baxter Healthcare Corporation
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2009-08-04
Decision date: 2009-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcgaw Park, IL, 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.