PORTA-FIB LPD— 510(k) K801544

Name: FDA 510(k) clearance K801544
Creator: U.S. Food and Drug Administration
Published: 1980-07-14

Substantially Equivalent

Narco Bio-Systems

FDA 510(k) clearance K801544 for PORTA-FIB LPD, Substantially Equivalent on 1980-07-14. Applicant: Narco Bio-Systems. Device class: 2.

Clearance details

Applicant: Narco Bio-Systems
Product code: Code LDD
Device class: Class 2
Regulation: 21 CFR 870.5300
Advisory panel: Cardiovascular
Date received: 1980-07-07
Decision date: 1980-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.