PACING LEAD MODELS, MDM 1060, MDM 1090— 510(k) K781620

Substantially Equivalent

R.E. Brown Co., Inc.

FDA 510(k) clearance K781620 for PACING LEAD MODELS, MDM 1060, MDM 1090, Substantially Equivalent on 1978-12-08. Applicant: R.E. Brown Co., Inc..

Clearance details

Applicant: R.E. Brown Co., Inc.
Product code: Code DTB
Advisory panel: Cardiovascular
Date received: 1978-09-20
Decision date: 1978-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.