DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML— 510(k) K020666
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K020666 for DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML, Substantially Equivalent on 2002-06-24. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code FMF
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Glendale, CA, US
Recent devices under product code FMF
view allMore clearances from Baxter Healthcare Corp
view all- K190910 — PrisMax System Version 2
- K163530 — PrisMax Control Unit
- K130531 — ULTRAFUSE
- K132734 — NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS
- K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
Adverse events under product code FMF
product code FMF- Death
- 15
- Injury
- 2,263
- Malfunction
- 29,722
- Other
- 17
- Total
- 32,017
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.