MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9
FDA 510(k) clearance K030149 · decided 2003-03-20
Clearance details
- K-number
- K030149
- Device name
- MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9
- Applicant
- Avail Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-01-15
- Decision date
- 2003-03-20
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic MiniMed Paradigm Quick-set Plus Infusion Sets. Models MMT-359S6; MMT-359S9; MMT3 recall (Z-0910-04) | Medtronic MiniMed | 2012-03-19 |