510(k) K905498 ยท LDR Controller, Infusion, Intravascular, Electronic
STAT 2 IV PUMPETTE
| Applicant | The Master Medical Corp., San Francisco CA, US |
| Decision | Substantially Equivalent, Apr 16, 1991 |
| Received | Dec 7, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905498
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 19, 2017 | ConMed Corporation STAT 2 I.V. Gravity Flow Controller and STAT 2 Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT 2 I.V. Controller, (2) S2-12, STAT 2 Extension Set Gravity Flow Terminated |
LDR | None listed |
| Jan 11, 2012 | ConMed Corporation STAT 2 I.V. Controller, Catalog/REF No. S2, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device with a sterile, nonpyrogenic fluid path.
For co Terminated |
LDR | None listed |
| Jan 11, 2012 | ConMed Corporation STAT 2 Pumpette I.V. Compensating Controller, Catalog/REF No. PS2, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device with a sterile, nonpyrogeni Terminated |
LDR | None listed |
| Jan 11, 2012 | ConMed Corporation STAT 2 Secondary Set Gravity Flow Controller, 20 Drops/cc, 13 in. length, Catalog/REF No. S2-20 MD, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a dis Terminated |
FPA | None listed |
| Jan 11, 2012 | ConMed Corporation STAT 2 Pumpette Extension Set Gravity Flow Compensating Controller, 12" length, Catalog/REF No. P-S2-12, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is Terminated |
LDR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.