DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System— 510(k) K171217
Substantially EquivalentOsprey Medical, Inc.
FDA 510(k) clearance K171217 for DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System, Substantially Equivalent on 2017-05-26. Applicant: Osprey Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Osprey Medical, Inc.
- Product code
- Code DXT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Minnetonka, MN, US
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More clearances from Osprey Medical, Inc.
view all- K190102 — DyeVert Plus Contrast Reduction System, DyeTect Contrast Monitoring System, DyeVert Plus EZ Contrast Reduction System
- K183267 — DyeVert NG Contrast Reduction System, DyeVert PLUS EZ Contrast Reduction System, DyeTect Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert PLUS EZ Contrast Reduction System
- K181936 — DyeVert PLUS EZ Contrast Reduction System
- K171698 — Smart Syringe
- K163054 — DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System
Adverse events under product code DXT
product code DXT- Death
- 39
- Injury
- 242
- Malfunction
- 463
- Other
- 3
- Total
- 747
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.