510(k) K991886 ยท KRB Probe, Thermodilution
PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR
| Applicant | Pulsion Medical Systems, Inc., Wilmington NC, US |
| Decision | Substantially Equivalent, May 11, 2000 |
| Received | Jun 2, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991886
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 17, 2015 | Pulsion Medical Inc Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package.
Product Usage:
Measures cardiac output by the thermodilution method, measure Terminated |
KRB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.