510(k) K080400 ยท MSD Catheter, Hemodialysis, Implanted
ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT
| Applicant | AngioDynamics, Inc., Queensburgy NY, US |
| Decision | Substantially Equivalent, May 13, 2008 |
| Received | Feb 13, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080400
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Angiodynamics, Inc. DURAMAX 15.5 F x 22 cm Chronic Hemodialysis Catheter Set (With Cuff 17 cm from Tip), DuraMax Stacked Tip 22 cm Str. Basic Kit, Catalog No./REF 10302802, STERILE --- AngioDynamics, Inc. 603 Queensbury, Terminated |
MSD | None listed |
| Jan 11, 2012 | Angiodynamics, Inc. DURAMAX 15.5 F x 24 cm Chronic Hemodialysis Catheter Set (With Cuff 19 cm from Tip), DuraMax Stacked Tip 24 cm Str. Basic Kit, Catalog No./REF 10302803, STERILE --- AngioDynamics, Inc. 603 Queensbury Terminated |
MSD | None listed |
| Jan 11, 2012 | Angiodynamics, Inc. DURAMAX 15.5 F x 28 cm Chronic Hemodialysis Catheter Set (With Cuff 23 cm from Tip), DuraMax Stacked Tip 28 cm Str. Basic Kit, Catalog No./REF 10302804, STERILE --- AngioDynamics, Inc. 603 Queensbury Terminated |
MSD | None listed |
| Jan 11, 2012 | Angiodynamics, Inc. DURAMAX 15.5 F x 32 cm Chronic Hemodialysis Catheter Set (With Cuff 27 cm from Tip), DuraMax Stacked Tip 32 cm Str. Basic Kit, Catalog No./REF 10302805, STERILE --- AngioDynamics, Inc. 603 Queensbury Terminated |
MSD | None listed |
| Jan 11, 2012 | Angiodynamics, Inc. DURAMAX 15.5 F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31 cm from Tip), DuraMax Stacked Tip 36 cm Str. Basic Kit, Catalog No./REF 10302806, STERILE --- AngioDynamics, Inc. 603 Queensbury, Terminated |
MSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.