MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS— 510(k) K932172

Unknown

Medtronic Vascular

FDA 510(k) clearance K932172 for MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS, Unknown on 1993-12-08. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code DTB
Advisory panel: Cardiovascular
Date received: 1993-05-05
Decision date: 1993-12-08
Decision: Unknown
Clearance type: Traditional
Location: Minneapolis, 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.