510(k) K952074 ยท FPA Set, Administration, Intravascular
SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Jul 27, 1995 |
| Received | May 2, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952074
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore,
1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47 centimeters), Product Code 2H8603 Open, Classified |
FMG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.