ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860— 510(k) K851731

Substantially Equivalent

Ela Medical, Inc.

FDA 510(k) clearance K851731 for ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860, Substantially Equivalent on 1985-08-29. Applicant: Ela Medical, Inc..

Clearance details

Applicant: Ela Medical, Inc.
Product code: Code DTB
Advisory panel: Cardiovascular
Date received: 1985-04-25
Decision date: 1985-08-29
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.