BARD MINI-INFUSER 1500 & 3000
FDA 510(k) clearance K930459 · decided 1993-08-10
Clearance details
- K-number
- K930459
- Device name
- BARD MINI-INFUSER 1500 & 3000
- Applicant
- Bard Medsystems Div.
- Decision
- Substantially Equivalent
- Date received
- 1993-01-28
- Decision date
- 1993-08-10
- Days to decision
- 194 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- North Reading, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusi recall (Z-2268-2012) | Baxter Healthcare Corp. | 2012-08-24 |
| Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion recall (Z-2269-2012) | Baxter Healthcare Corp. | 2012-08-24 |