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

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..

Clearance details

Applicant: Medtronic, Inc.
Product code: Code DSA
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 ↗

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.