TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T— 510(k) K012743
Substantially EquivalentMedtronic Perfusion Systems
FDA 510(k) clearance K012743 for TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T, Substantially Equivalent on 2001-09-14. Applicant: Medtronic Perfusion Systems. Device class: 2.
Clearance details
- Applicant
- Medtronic Perfusion Systems
- Product code
- Code DRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.4330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Minneapolis, MN, US
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Adverse events under product code DRY
product code DRY- Death
- 5
- Total
- 5
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.