AVERT Contrast Modulation System (3 models)— 510(k) K152218
Substantially EquivalentOsprey Medical
FDA 510(k) clearance K152218 for AVERT Contrast Modulation System (3 models), Substantially Equivalent on 2015-09-21. Applicant: Osprey Medical. Device class: 2.
Clearance details
- Device name as filed
- AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System
- Applicant
- Osprey Medical
- 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
- Traditional
- 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, 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.