510(k) K052828 ยท DRS Transducer, Blood-Pressure, Extravascular
DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)
| Applicant | Hospira, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Feb 17, 2006 |
| Received | Oct 5, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052828
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 27, 2018 | ICU Medical, Inc. ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06, Sterile EO Terminated |
DRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.