PARADIGM QUICK-SET INFUSION SET
FDA 510(k) clearance K011071 · decided 2001-06-07
Clearance details
- K-number
- K011071
- Device name
- PARADIGM QUICK-SET INFUSION SET
- Applicant
- Maersk Medical A/S
- Decision
- Substantially Equivalent
- Date received
- 2001-04-09
- Decision date
- 2001-06-07
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- 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 Sets The Paradigm infusion sets are intended f recall (Z-1668-2013) | Medtronic MiniMed | 2013-07-09 |
| Paradigm Quick-set Infusion Sets, Models MMT-396, MMT-397, MMT-398 and MMT-399. The Paradi recall (Z-1705-2009) | Medtronic MiniMed | 2009-07-16 |