CADD-MS 3 AMBULATORY INFUSION PUMP
FDA 510(k) clearance K051568 · decided 2005-11-17
Clearance details
- K-number
- K051568
- Device name
- CADD-MS 3 AMBULATORY INFUSION PUMP
- Applicant
- Smiths Medical MD, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-06-14
- Decision date
- 2005-11-17
- Days to decision
- 156 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CADD-MS"3 Ambulatory Infusion Pumps, Model 7400, Rx only, CE 0473, SN 499000. The device i recall (Z-1641-2008) | Smiths Medical MD, Inc. | 2008-08-24 |
| CADD-MS 3 Ambulatory Infusion Pump, Model 7400 Smiths Medical MD, Inc., St. Paul, MN 55112 recall (Z-1621-2008) | Smiths Medical MD, Inc. | 2008-08-15 |