510(k) K100434 ยท FPA Set, Administration, Intravascular
CLAVE NEUTRON
| Applicant | Icu Medical, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jul 9, 2010 |
| Received | Feb 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100434
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2022 | ICU Medical, Inc. MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery. Open, Classified |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. NanoClave Connector; 1 unit per pouch, 100 multivac pouches per case;UDI (01)10887709051017(17)241201(30)100(10)4549051; (01)10887709051017(17)241101(30)100(10)4447754
CLAVE Neutron is a normally cl Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case.
UDI:(01)10887709058757(17)250101(30)100(10)4573278;
(01)10887709058757(17)250101(30)100(10)4590919;
(01)10887709058757(17)250201(3 Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.