Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables— 510(k) K203556

Name: FDA 510(k) clearance K203556
Creator: U.S. Food and Drug Administration
Published: 2021-07-12

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K203556 for Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables, Substantially Equivalent on 2021-07-12. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Product code DSA
Device class: Class 2
Regulation: 21 CFR 870.2900
Advisory panel: Cardiovascular
Date received: 2020-12-07
Decision date: 2021-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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.