MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP— 510(k) K041318
Substantially EquivalentMedtronic Minimed
FDA 510(k) clearance K041318 for MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP, Substantially Equivalent on 2004-07-19. Applicant: Medtronic Minimed. Device class: 2.
Clearance details
- Applicant
- Medtronic Minimed
- Product code
- Code LZG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Northridge, CA, US
Recent devices under product code LZG
view allMore clearances from Medtronic Minimed
view allAdverse events under product code LZG
product code LZG- Death
- 104
- Injury
- 12,022
- Malfunction
- 135,004
- Other
- 1
- Total
- 147,131
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 K041318
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 K041318.
Data sourced from openFDA. This site is unofficial and independent of the FDA.