I-FLOW ELASTOMERIC PUMP WITH BOLUS
FDA 510(k) clearance K023318 · decided 2002-10-18
Clearance details
- K-number
- K023318
- Device name
- I-FLOW ELASTOMERIC PUMP WITH BOLUS
- Applicant
- I-Flow Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-10-04
- Decision date
- 2002-10-18
- Days to decision
- 14 days
- Clearance type
- Special
- Product code
- MEB
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lake Forest, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a recall (Z-2253-2012) | I-Flow Corporation | 2012-08-28 |