INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES— 510(k) K062457
Substantially EquivalentBaxter Healthcare Corporation
FDA 510(k) clearance K062457 for INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES, Substantially Equivalent on 2006-09-21. Applicant: Baxter Healthcare Corporation. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corporation
- Product code
- Code MEB
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mcgaw Park, IL, US
Recent devices under product code MEB
view allMore clearances from Baxter Healthcare Corporation
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 MEB
product code MEB- Death
- 6
- Injury
- 160
- Malfunction
- 10,053
- Other
- 5
- Total
- 10,224
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 →
Recalls naming K062457
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062457.
Data sourced from openFDA. This site is unofficial and independent of the FDA.