EXTERNAL PULSE GENERATOR - EV4542— 510(k) K821791

Name: FDA 510(k) clearance K821791
Creator: U.S. Food and Drug Administration
Published: 1982-07-06

Substantially Equivalent

American Pacemaker Corp.

FDA 510(k) clearance K821791 for EXTERNAL PULSE GENERATOR - EV4542, Substantially Equivalent on 1982-07-06. Applicant: American Pacemaker Corp.. Device class: 2.

Clearance details

Applicant: American Pacemaker Corp.
Product code: Code DTE
Device class: Class 2
Regulation: 21 CFR 870.3600
Advisory panel: Cardiovascular
Date received: 1982-06-17
Decision date: 1982-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from American Pacemaker Corp.

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K810396 — APC IMPLANTABLE PACING LEAD, TINED #32621981-05-15
K810397 — APC IMPLANTABLE PACING LEAD-FLANGE #32601981-05-15
K810398 — APC IMPLANTABLE PACING LEAD, MODEL 32661981-05-15

Adverse events under product code DTE

product code DTE

Death: 18
Injury: 247
Malfunction: 4,603
Total: 4,868

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.