FLEXON TEMPORARY CARDIAC PACER LEAD— 510(k) K955722

Substantially Equivalent

Davis & Geck, Inc.

FDA 510(k) clearance K955722 for FLEXON TEMPORARY CARDIAC PACER LEAD, Substantially Equivalent on 1996-03-15. Applicant: Davis & Geck, Inc..

Clearance details

Applicant: Davis & Geck, Inc.
Product code: Code LDF
Advisory panel: Cardiovascular
Date received: 1995-12-18
Decision date: 1996-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danbury, CT, 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.