PARADIGM 1.5ML RESERVOIR, MODEL 326
FDA 510(k) clearance K001828 · decided 2000-08-18
Clearance details
- K-number
- K001828
- Device name
- PARADIGM 1.5ML RESERVOIR, MODEL 326
- Applicant
- Minimed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-06-16
- Decision date
- 2000-08-18
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Sylmar, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The recall (Z-1986-2013) | Medtronic MiniMed | 2013-08-20 |