TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6— 510(k) K133157

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K133157 for TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6, Substantially Equivalent on 2014-10-23. Applicant: Medtronic, Inc..

Clearance details

Applicant: Medtronic, Inc.
Product code: Code DRY
Advisory panel: Cardiovascular
Date received: 2013-10-17
Decision date: 2014-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
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, 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.