SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD— 510(k) K874465

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K874465 for SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD, Substantially Equivalent on 1988-05-25. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DYG
Advisory panel: Cardiovascular
Date received: 1987-10-30
Decision date: 1988-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

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Adverse events under product code DYG

product code DYG

Death: 18
Malfunction: 1,051
Other: 1
Total: 1,070

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.