510(k) K943897 ยท FPA Set, Administration, Intravascular
NU-SITE
| Applicant | Medex, Inc., Hilliard OH, US |
| Decision | Substantially Equivalent, Feb 10, 1995 |
| Received | Aug 10, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943897
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2024 | Smiths Medical Asd Inc 1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL Open, Classified |
DRS | None listed |
| Jan 17, 2024 | Smiths Medical Asd Inc 6IN PRESSURE TUBING, List Number MX20617 Open, Classified |
DRS | None listed |
| Jan 17, 2024 | Smiths Medical Asd Inc Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R Open, Classified |
DRS | None listed |
| Jan 17, 2024 | Smiths Medical Asd Inc HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP Open, Classified |
DRS | None listed |
| Jan 17, 2024 | Smiths Medical Asd Inc HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP Open, Classified |
DRS | None listed |
| Jan 17, 2024 | Smiths Medical Asd Inc Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R Open, Classified |
DRS | None listed |
| Jan 17, 2024 | Smiths Medical Asd Inc 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R Open, Classified |
DRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.