PORTA FIB III— 510(k) K822961

Substantially Equivalent

Narco Scientific

FDA 510(k) clearance K822961 for PORTA FIB III, Substantially Equivalent on 1982-11-01. Applicant: Narco Scientific.

Clearance details

Applicant: Narco Scientific
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1982-10-05
Decision date: 1982-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.