510(k) K053106 ยท FPA Set, Administration, Intravascular
TEGO, MODEL D1000
| Applicant | Icu Medical, Inc., San Clemente CA, US |
| Decision | Substantially Equivalent, Jan 10, 2006 |
| Received | Nov 4, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053106
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2026 | ICU Medical, Inc. Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000 Open, Classified |
FPA | None listed |
| Jan 10, 2017 | ICU Medical, Inc. Tego Connector, Item No. D1000, NM1000
The Tego Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intr Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.