MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)— 510(k) K051253
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K051253 for MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM), Substantially Equivalent on 2005-07-15. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code MEA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mcgaw Park, IL, US
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Adverse events under product code MEA
product code MEA- Death
- 19
- Malfunction
- 25,089
- Total
- 25,108
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 K051253
K-number listed on FDA's recall record- Z-1536-2015 — The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus doses of medication based on patient demand.
- Z-1602-2013 — Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051253.
Data sourced from openFDA. This site is unofficial and independent of the FDA.