510(k) K020655 ยท LZG Pump, Infusion, Insulin
DELTEC INSULIN INFUSION PUMP AND ACCESSORIES
| Applicant | Deltec, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Aug 13, 2002 |
| Received | Mar 1, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020655
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2008 | Smiths Medical MD, Inc. Deltec Cozmo Insulin Pump, model 21-1700.
A syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion for the control of diabetes.
Reorder Numbers:
21-1701-02/32/33/36/44/49/51/54/6 Terminated |
LZG | None listed |
| Sep 1, 2008 | Smiths Medical MD, Inc. Deltec Cozmo Insulin Pump, model 21-1800.
This is similar to the currently distributed Deltec Cozmo Insulin Pump Model 1700, with the exception of updated software that enhanced certain features and Terminated |
LZG | None listed |
| Aug 15, 2008 | Smiths Medical MD, Inc. Deltec Cozmo Insulin Pump, Model 1700, Smiths Medical International Ltd WD24 4LG UK, Smiths Medical MD, Inc., St Paul, MN 55112. This is a syringe infusion pump intended for Continuous Subcutaneous I Terminated |
LZG | None listed |
| Feb 26, 2005 | Smiths Medical MD, Inc. Deltec Cozmo 3 ml Insulin Cartridge with 0.7mm(22G) x 12.5mm (1/2 in.) needle and cap. Reorder No. 21-1750-24. Immediate container states STERILE EO, Rx Only , Deltec, Inc., St. Paul, MN 55112. Terminated |
LZG | None listed |
| Nov 19, 2004 | Smiths Medical MD, Inc. Deltec Cozmo Insulin Pump Terminated |
LZG | None listed |
| May 9, 2003 | Deltec, Inc Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Numbers 21-1711-01, 21-1712-01 and 21-1713-01. The 3 versions vary only in the color of the exterior. Terminated |
LZG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.