MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712— 510(k) K031390
Substantially EquivalentMinimed, Inc.
FDA 510(k) clearance K031390 for MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712, Substantially Equivalent on 2003-07-23. Applicant: Minimed, Inc.. Device class: 2.
Clearance details
- Applicant
- Minimed, Inc.
- Product code
- Code LGZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northridge, CA, US
Recent devices under product code LGZ
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- K030531 — MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER
- K021974 — MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311
- K010377 — MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385
- K001827 — PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325
Adverse events under product code LGZ
product code LGZ- Death
- 16
- Malfunction
- 5,916
- Other
- 1
- Total
- 5,933
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K031390
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031390.
Data sourced from openFDA. This site is unofficial and independent of the FDA.