MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER
FDA 510(k) clearance K030531 · decided 2003-06-17
Clearance details
- K-number
- K030531
- Device name
- MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER
- Applicant
- Minimed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-02-19
- Decision date
- 2003-06-17
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- LZG
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Northridge, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models: MMT-5 recall (Z-1007-2007) | Medtronic MiniMed | 2007-07-07 |
| BD Test Strips. The US market BD Test Strips are identified by Catalog Numbers 322027 (50 recall (Z-0763-04) | Becton Dickinson & Company | 2004-07-20 |