510(k) K102043 ยท MSD Catheter, Hemodialysis, Implanted
ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER
| Applicant | Rex Medical, Great Neck NY, US |
| Decision | Substantially Equivalent, Nov 18, 2010 |
| Received | Jul 20, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102043
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2014 | Argon Medical Devices, Inc UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (36 cm) and 32102540 (40 cm). The Rex Medical UltraStream Chronic Terminated |
MSD | None listed |
| Sep 24, 2014 | Argon Medical Devices, Inc UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a c Terminated |
MSD | None listed |
| Sep 24, 2014 | Argon Medical Devices, Inc UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (40 cm)
The Rex Medical UltraStream Chronic Hemodialysis Catheter is a Terminated |
MSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.