JELCO* DISC FILTER-0.2 MICRON— 510(k) K790471

Name: FDA 510(k) clearance K790471
Creator: U.S. Food and Drug Administration
Published: 1979-04-30

Substantially Equivalent

Jelco Laboratories

FDA 510(k) clearance K790471 for JELCO* DISC FILTER-0.2 MICRON, Substantially Equivalent on 1979-04-30. Applicant: Jelco Laboratories. Device class: 2.

Clearance details

Applicant: Jelco Laboratories
Product code: Code FPB
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1979-03-05
Decision date: 1979-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K791918 — JELCO WINGED INTRAVASCULAR CATHETER1979-10-02
K791372 — JELCO & KVO CATHETER PLACEMENT UNIT1979-09-12
K790967 — CATHETER METAL HUB/RADIOPAQUE1979-06-27
K790968 — CATHETER METAL HUB/NONRADIOPAQUE1979-06-11
K790186 — PROTECTIVSTABILIZER1979-02-26

Adverse events under product code FPB

product code FPB

Other: 1
Total: 1

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.