UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492— 510(k) K944966

Substantially Equivalent

Medtronic Blood Systems, Inc.

FDA 510(k) clearance K944966 for UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492, Substantially Equivalent on 1995-07-14. Applicant: Medtronic Blood Systems, Inc..

Clearance details

Applicant: Medtronic Blood Systems, Inc.
Product code: Code LDF
Advisory panel: Cardiovascular
Date received: 1994-10-11
Decision date: 1995-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code LDF

product code LDF

Death: 19
Injury: 188
Malfunction: 694
Other: 1
Total: 902

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.