BARD MINI-INFUSER 1500 & 3000— 510(k) K930459
Substantially EquivalentBard Medsystems Div.
FDA 510(k) clearance K930459 for BARD MINI-INFUSER 1500 & 3000, Substantially Equivalent on 1993-08-10. Applicant: Bard Medsystems Div.. Device class: 2.
Clearance details
- Applicant
- Bard Medsystems Div.
- Product code
- Code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Reading, MA, US
Recent devices under product code FRN
view all- K253703 — RemunityPRO+ Pump for Remodulin® (treprostinil) Injection
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- K242752 — MRidium 3870 MRI Infusion Pump System (3870)
Adverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
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 K930459
K-number listed on FDA's recall record- Z-2268-2012 — Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump; Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage: The Mini-Infuser System is designed for controlled intermittent administration of intravenous medication.
- Z-2269-2012 — Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion pump with an active time scale and rate selector switch; product codes 2M8171 and 2M8171R. Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage: The Mini-Infuser System is designed for controlled intermittent administration of intravenous medication.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K930459.
Data sourced from openFDA. This site is unofficial and independent of the FDA.