PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB— 510(k) K020669

Substantially Equivalent

Oscor, Inc.

FDA 510(k) clearance K020669 for PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB, Substantially Equivalent on 2002-03-28. Applicant: Oscor, Inc..

Clearance details

Applicant: Oscor, Inc.
Product code: Code DTB
Advisory panel: Cardiovascular
Date received: 2002-03-01
Decision date: 2002-03-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Palm Harbor, FL, 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.