DELTEC INSULIN INFUSION PUMP AND ACCESSORIES
FDA 510(k) clearance K020655 · decided 2002-08-13
Clearance details
- K-number
- K020655
- Device name
- DELTEC INSULIN INFUSION PUMP AND ACCESSORIES
- Applicant
- Deltec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-03-01
- Decision date
- 2002-08-13
- Days to decision
- 165 days
- Clearance type
- Traditional
- Product code
- LZG
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Deltec Cozmo Insulin Pump, model 21-1700. A syringe infusion pump designed for Continuous recall (Z-1590-2008) | Smiths Medical MD, Inc. | 2008-09-01 |
| Deltec Cozmo Insulin Pump, model 21-1800. This is similar to the currently distributed Del recall (Z-1591-2008) | Smiths Medical MD, Inc. | 2008-09-01 |
| Deltec Cozmo Insulin Pump, Model 1700, Smiths Medical International Ltd WD24 4LG UK, Smith recall (Z-1622-2008) | Smiths Medical MD, Inc. | 2008-08-15 |
| Deltec Cozmo 3 ml Insulin Cartridge with 0.7mm(22G) x 12.5mm (1/2 in.) needle and cap. Reo recall (Z-0566-05) | Smiths Medical MD, Inc. | 2005-02-26 |
| Deltec Cozmo Insulin Pump recall (Z-0210-05) | Smiths Medical MD, Inc. | 2004-11-19 |
| Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Numbers 21-1711-01, 21-1712-01 and recall (Z-0798-03) | Deltec, Inc | 2003-05-09 |