510(k) K052221 ยท FRN Pump, Infusion
AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP
| Applicant | Sorenson Medical, Inc., West Jordan UT, US |
| Decision | Substantially Equivalent, Dec 8, 2005 |
| Received | Aug 15, 2005 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K052221
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2006 | Sorenson Medical, Inc. ambIT Ambulatory Infusion Pump Cassette; Filterless, Spike, Sterile, Vol. 2.3ml, REF 220139, Sorenson Medical, Inc., West Jordan, Utah Terminated |
FRN | None listed |
| Nov 16, 2006 | Sorenson Medical, Inc. ambIT Ambulatory Infusion Pump Cassette; Filter, Spike, Sterile, Vol. 2.3ml, REF 220140, Sorenson Medical, Inc., West Jordan, Utah. Terminated |
FRN | None listed |
| Nov 16, 2006 | Sorenson Medical, Inc. ambIT Ambulatory Infusion Pump Cassette; Filter, Male, Sterile, Vol. 2.3ml, REF 220266, Sorenson Medical, Inc., West Jordan, Utah. Terminated |
FRN | None listed |
| Nov 16, 2006 | Sorenson Medical, Inc. ambIT Ambulatory Infusion Pump Cassette; Filterless, Male, Sterile, Vol. 2.3ml, REF 220267, Sorenson Medical, Inc., West Jordan, Utah. Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.