AMBIT CONTINUOUS AMBULATORY INFUSION PUMP
FDA 510(k) clearance K033325 · decided 2003-11-06
Clearance details
- K-number
- K033325
- Device name
- AMBIT CONTINUOUS AMBULATORY INFUSION PUMP
- Applicant
- Sorenson Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-10-16
- Decision date
- 2003-11-06
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- West Jordan, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ambIT Ambulatory Infusion Pump Cassette; Filterless, Spike, Sterile, Vol. 2.3ml, REF 22013 recall (Z-0185-2007) | Sorenson Medical, Inc. | 2006-11-16 |
| ambIT Ambulatory Infusion Pump Cassette; Filter, Spike, Sterile, Vol. 2.3ml, REF 220140, S recall (Z-0186-2007) | Sorenson Medical, Inc. | 2006-11-16 |
| ambIT Ambulatory Infusion Pump Cassette; Filter, Male, Sterile, Vol. 2.3ml, REF 220266, So recall (Z-0187-2007) | Sorenson Medical, Inc. | 2006-11-16 |
| ambIT Ambulatory Infusion Pump Cassette; Filterless, Male, Sterile, Vol. 2.3ml, REF 220267 recall (Z-0188-2007) | Sorenson Medical, Inc. | 2006-11-16 |