510(k) K003245 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Dec 4, 2000 |
| Received | Oct 17, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K003245
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2003 | Baxter Healthcare Corp. 10 U/mL Heparin Lock Flush Solution USP, 5mL in 12 mL Syringe, code 2K6030; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case Terminated |
FOZ | None listed |
| Jan 23, 2003 | Baxter Healthcare Corp. 100 U/mL Heparin Lock Flush Solution USP; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case Terminated |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.