BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE— 510(k) K092318
Substantially EquivalentBaxter 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. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corporation
- Product code
- Code LHI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mcgaw Park, IL, US
Recent devices under product code LHI
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view all- K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
- K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
- K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library
- K243529 — Solution Administration Sets
- K242339 — Intravascular Extension Sets and Accessories
Adverse events under product code LHI
product code LHI- Injury
- 207
- Malfunction
- 7,820
- Other
- 3
- Total
- 8,030
Source: openFDA MAUDE database, through . 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.