LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO— 510(k) K861440

Substantially Equivalent

Pacesetter Systems

FDA 510(k) clearance K861440 for LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO, Substantially Equivalent on 1986-05-13. Applicant: Pacesetter Systems.

Clearance details

Applicant: Pacesetter Systems
Product code: Code DTB
Advisory panel: Cardiovascular
Date received: 1986-04-17
Decision date: 1986-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, US

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Adverse events under product code DTB

product code DTB

Death: 1,491
Injury: 67,311
Malfunction: 79,368
Other: 10
Total: 148,180

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.