510(k) K964844 ยท FPA Set, Administration, Intravascular
CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS
| Applicant | Conmedcorp, Utica NY, US |
| Decision | Substantially Equivalent, Mar 24, 1997 |
| Received | Dec 3, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964844
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 19, 2017 | ConMed Corporation STAT 2 I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog Numbers: (1) S2-12 N, STAT 2 Extension Set Gravity Flow Controller (Needle-Free), 12 length, (2) Terminated |
FPA | None listed |
| Jan 11, 2012 | ConMed Corporation STAT 2 Extension Set Gravity Flow Controller, 12 in. length, Catalog/REF No. S2-12, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device w Terminated |
FPA | None listed |
| Jan 11, 2012 | ConMed Corporation STAT 2 Extension Set Gravity Flow Controller (Needle-Free), 12 in. length, Catalog/REF No. S2-12N, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disp Terminated |
FPA | None listed |
| Jan 11, 2012 | ConMed Corporation STAT 2 Primary Administration Set Gravity Flow Controller, 20 Drops/cc, 84 in. length, Catalog/REF No. S2V-20, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- Th Terminated |
FPA | None listed |
| Jan 11, 2012 | ConMed Corporation STAT 2 Primary Administration Set Gravity Flow Controller (Needle-Free), 20 Drops/cc, 84 in. length, Catalog/REF No. S2V-20 N, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, Terminated |
FPA | None listed |
| Jan 11, 2012 | ConMed Corporation STAT 2 Primary Administration Set Gravity Flow Controller, 60 Drops/cc, 84 in. length, Catalog/REF No. S2V-60, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- Th Terminated |
FPA | None listed |
| Jan 11, 2012 | ConMed Corporation STAT 2 Primary Administration Set Gravity Flow Controller (Needle-Free), 60 Drops/cc, 84 in. length, Catalog/REF No. S2V-60 N, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, Terminated |
FPA | None listed |
| Jan 11, 2012 | ConMed Corporation STAT 2 Pumpette Extension Set Gravity Flow Compensating Controller (Needle-Free), 12 length, Catalog/REF No. P-S2-12 N, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 135 Terminated |
FPA | None listed |
| Jan 11, 2012 | ConMed Corporation STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller, 20 Drops/cc, 84" length, Catalog/REF No. P-S2V-20, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, U Terminated |
FPA | None listed |
| Jan 11, 2012 | ConMed Corporation STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller (Needle-Free), 20 Drops/cc, 84" length, Catalog/REF No. P-S2V-20 N, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 52 Terminated |
FPA | None listed |
| Jan 11, 2012 | ConMed Corporation STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller, 60 Drops/cc, 84" length, Catalog/REF No. P-S2V-60, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, U Terminated |
FPA | None listed |
| Jan 11, 2012 | ConMed Corporation STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller (Needle-Free), 60 Drops/cc, 84 length, Catalog/REF No. P-S2V-60 N, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.