DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE.— 510(k) K891122

Name: FDA 510(k) clearance K891122
Creator: U.S. Food and Drug Administration
Published: 1989-09-13

Substantially Equivalent

Big Valley Medical

FDA 510(k) clearance K891122 for DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE., Substantially Equivalent on 1989-09-13. Applicant: Big Valley Medical. Device class: 2.

Clearance details

Applicant: Big Valley Medical
Product code: Code LDD
Device class: Class 2
Regulation: 21 CFR 870.5300
Advisory panel: Cardiovascular
Date received: 1989-03-02
Decision date: 1989-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangevale, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

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.