PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318— 510(k) K001832
Substantially EquivalentMinimed, Inc.
FDA 510(k) clearance K001832 for PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318, Substantially Equivalent on 2000-08-18. Applicant: Minimed, Inc.. Device class: 2.
Clearance details
- Applicant
- Minimed, Inc.
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sylmar, CA, US
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More clearances from Minimed, Inc.
view all- K031541 — PARADIGMPAL, MODEL MMT-7330
- K031390 — MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712
- 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
Adverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.