510(k) K915265 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
CDI(TM) H/S CUVETTE, MODIFICATION
| Applicant | 3M Company, Tustin CA, US |
| Decision | Substantially Equivalent, Jan 15, 1992 |
| Received | Nov 19, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915265
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2015 | Terumo Cardiovascular Systems Corporation CDI H/S Cuvette
The intended use for the CDI H IS Cuvette is as follows: The CDI H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitori Terminated |
DRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.