DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System— 510(k) K171217

Substantially Equivalent

Osprey 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..

Clearance details

Applicant: Osprey Medical, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 2017-04-26
Decision date: 2017-05-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Minnetonka, MN, US

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Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.