510(k) K970438 ยท FPA Set, Administration, Intravascular
INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Apr 2, 1997 |
| Received | Feb 5, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970438
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2010 | Baxter Healthcare Corp. Baxter Interlink System, Micro-Infusion Manifold; and Interlink Manifold. An Rx sterile device with 3 injection sites, volume per injection site 0.1 mL, priming volume 0.8 mL, length 8.7 cm. Product Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.