FOCUS J81F, J83F, J41F, J43F PACING LEADS— 510(k) K896742

Substantially Equivalent

Ela Medical, Inc.

FDA 510(k) clearance K896742 for FOCUS J81F, J83F, J41F, J43F PACING LEADS, Substantially Equivalent on 1990-07-17. Applicant: Ela Medical, Inc..

Clearance details

Applicant: Ela Medical, Inc.
Product code: Code DTB
Advisory panel: Cardiovascular
Date received: 1989-11-30
Decision date: 1990-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, 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.