510(k) K993120 ยท BRZ Set, Blood Transfusion
MODIFIED BLOOD RECIPIENT SET
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Nov 17, 1999 |
| Received | Sep 20, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993120
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2004 | Baxter Healthcare Corp. Baxter Clearlink Intravenous (IV) Delivery System; the system consists of solution sets, extension sets and blood sets that have a luer activated valve for IV access, which allows the administration Terminated |
FPA | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Baxter Y-Type Blood/Solution Set, 10 drops/mL, 112'', Standard Blood Filter, 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 2C6750; Baxter Healthcare Corporation, Deerfield, Terminated |
BRZ | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Clearlink System Y-Type Blood/Solution Set, 10 drops/mL, 112'', Standard Blood Filter, 170 to 260 Micron Filter, Luer Activated Valve, Male Luer Lock Adapter, catalog 2C8750; Baxter Healthcare Corpora Terminated |
KSB | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter and Pressure Pump, 15 drops/mL, 99'', 170 to 260 Micro Filter, Large Standard Blood Filter, 2 Injection Sites, Male Luer Lock Adapter, Terminated |
KSB | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Baxter Y-Type Blood/Solution Set, 10 drops/mL, 115'', 80 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 2C7617; Baxter Healthcare Corporation, Deerfield, IL 60015 USA Terminated |
BRZ | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Baxter Y-Type Blood/Solution Set with Pressure Pump, 10 drops/mL, 99'', Large Standard Blood Filter, 170 to 260 Micron Filter, 2 Injection Sites, Male Luer Lock Adapter, catalog 2C7623; Baxter Healthc Terminated |
BRZ | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Fenwal Straight Type Blood Set with Large Standard Blood filter, 15 drops/mL, 80'', 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 4C6766; Baxter Healthcare Corporation, Dee Terminated |
BRZ | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 107'', 2 Injection Sites, Male Luer Lock Adapter, catalog 4C7774; Baxter Healthcare Corporation, Deerfield, IL 60015 USA Terminated |
BRZ | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 10 drops/mL, 82'', 170 to 260 Micron Filter, Large Bore Tubing, Male Luer Lock Adapter, catalog 4C7776; Baxter Healthcare Corporation Terminated |
BRZ | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Fenwal 3-Lead Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 82'', 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 4C7784; Baxter Healthcare Corporation, D Terminated |
BRZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.